COVID-19 IgG/IgM Rapid Test

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase

immunochromatographic assay for the rapid, qualitative and differential detection of IgG and
IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.

Features & Benefits

• Fast results as soon as 2-10 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• Little specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity

Test Procedure & Interpretation

1 drop of whole blood 2 drops of buffer

Specimen Line
ID
ID

ID

B
B

M
G
C
S
M
G
C

M
G
C
S

10 min

C C C C C C C C
G G G G G G G G
M M M M M M M M

IgM IgG IgG&IgM

Ordering Information
Product Description Specimen Catalog No. Format Kit Size
COVID-19 IgG/IgM Rapid Test Whole Blood/Serum/Plasma GCCOV-402a Cassette 25 Tests/Kit

HealgenScientificLLC
3818 Fuqua Street Houston, TX 77047, Texas, USDA
Other Products of Rapid Test www.healgen.com

Production Base :
Zhejiang Orient Gene Biotech Co., Ltd.
3787# East Yangguan Avenue,

For more detail product information, please contact us or visit : www.bintangmonoindonesia.com

Authorized Distribution by : PT. Bintang MONO Indonesia
HEALGEN COVID-19 IgG/IgM RAPID TEST CASSETTE

No Spesifikasi Produk
1 Nama Produk HEALGEN COVID-19 IgG/IgM RAPID
TEST CASSETTE
2 Merek HEALGEN
4 Prinsip Pemeriksaan Immunochromatography Test
5 Kemasan 1 Box terdiri atas 25 Test Cassette
Setiap Test Device terbungkus aluminium
foil dalam box asli pabrik & tercantum
masa kadaluarsa
Needle (Lancet)
Alcohol Pad
Pipet
Buffer
Paket Insert
6 Kemampuan Deteksi Kemampuan mendeteksi antibody IgG
dan IgM secara kualitatif terhadap Novel
Coronavirus 2019 dalam darah, serum
atau plasma manusia.

Hasil pemeriksaan 2 - 10 menit

7 Hasil Test Kualitatif
8 Spesimen Whole Blood, Serum atau Plasma
9 Volume Sampel 10 µl untuk whole bood dan 5 µl untuk
serum plasma
10 Sensitivitas dan Spesivisitas Hasil Clinical Sample Study Report
menunjukan :

 The specificity of lgM is 100%

(14/14) & the sensitivity test is 87.9%
(87/99) comparison to RT-PCR.

 The sensitivity of lgG test is 97.2%

(35/36) during the convalescence period
& The specificity of lgM is 100%
(14/14)..

11 Suhu Penyimpanan 2-30° C

12 Kadaluarsa 24 bulan dari tanggal produksi
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2) 2019ˉ nc° V Direct qPcR Kit

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Authority according to ArticIe10(3)°fthe above menti0ned DIrect∶ ve on the dates of
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 浙江东方基因生物制品有限公司
Zhejiang Orient Gene Biotech Co.,LTD
CE-DOC-OG127
version 1.0

EC Declaration of Conformity
In accordance with Directive 98/79/EC

Legal Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd

Legal Manufacturer Address: 3787#, East Yangguang Avenue, Dipu Street,

Anji 313300, Huzhou, Zhejiang,China

Declares, that the products

Product Name and Model(s)

COVID-19 IgG/IgM Rapid Test Cassette (Whole

GCCOV-402a
Blood/Serum/Plasma)

Classification: Other
Conformity assessment route: Annex III (EC DECLARATION OF CONFORMITY)

We, the Manufacturer, herewith declare with sole responsibility that our product/s mentioned
above meet/s the provisions of the Directive 98/79/EC of the European Parliament and of the
Council on In-Vitro Diagnostic Medical Devices.

We hereby explicitly appoint

EC Representative’s Name: Shanghai International Holding Corp. GmbH (Europe)

EC Representative’s Address: Eiffestrasse 80, 20537 Hamburg，Germany

to act as our European Authorized Representative as defined in the aforementioned Directive.

I, the undersigned,hereby declare that the medical devices specified above conform with the directive
98/79/EC on in vitro diagnostic medical devices and pertinent essential requirements

Date Signed: _February 12, 2020

____________________________________
Name of authorized signatory: Joyce Pang
Position held in the company: Vice-President
 May 29, 2020

Jinjie Hu, Ph.D.

Axteria BioMed Consulting Inc.
Representing: Healgen Scientific LLC
8040 Cobble Creek Circle
Potomac, MD 20854

Device: COVID-19 IgG/IgM Rapid Test Cassette (Whole

Blood/Serum/Plasma)
Company: Healgen Scientific LLC
Indication: Qualitative detection and differentiation of IgM and IgG antibodies
against SARS-CoV-2 in human venous whole blood, plasma (Li+-
heparin, K2-EDTA and sodium-citrate), and serum. Intended for
use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform
moderate or high complexity tests.

Dear Dr. Hu:

This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an
Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section
564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of
HHS then declared that circumstances exist justifying the authorization of emergency use of in

1
For ease of reference, this letter will use the term “you” and related terms to refer to Healgen Scientific LLC
2
For ease of reference, this letter will use the term “your product” to refer to the COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma) for the indication identified above.
Page 2 – Jinjie Hu, Healgen Scientific LLC

vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the
terms of any authorization issued under Section 564(a) of the Act.3

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the Scope of
Authorization of this letter (Section II), subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:

1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,

including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe

that your product may be effective in diagnosing recent or prior infection with SARS-
CoV-2 by identifying individuals with an adaptive immune response to the virus that
causes COVID-19, and that the known and potential benefits of your product when used
for such use, outweigh the known and potential risks of your product; and

3. There is no adequate, approved, and available alternative to the emergency use of your
product. 4

II. Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited to the indication above.

Authorized Product Details

Your product is a qualitative test for the detection and differentiation of IgM and IgG antibodies
against SARS-CoV-2 in venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-
citrate), and serum. The product is intended for use as an aid in identifying individuals with an
adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is
unknown for how long antibodies persist following infection and if the presence of antibodies
confers protective immunity.

To use your product, the device cassette, specimen, and sample buffer are allowed to equilibrate
to room temperature. Serum and plasma (5 µL) or one drop of venous whole blood (10 µL) is
transferred to the specimen well. Then 2 drops of sample buffer are added to the buffer well.
Wait for 10 minutes and read the test results. Results are not to be read after 15 minutes. An IgM
Positive Result occurs when a colored line appears at the M Test Line (M) region and the colored

3
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020).
4
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
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 Nomor : B-907893/BNPB/HOKS/HK.10.01/05/2020 26 Mei 2020
Lampiran : 1 (satu) berkas
Sifat : Sangat Penting
Hal : Pengecualian Ketentuan Tata Niaga Impor

Yth. KEPALA KANTOR PELAYANAN UTAMA BEA DAN CUKAI TIPE C

SOEKARNO-HATTA
Di Tempat
Sehubungan dengan impor barang untuk keperluan penanganan Corona
Virus Disease (Covid-19) oleh BINTANG MONO INDONESIA, dengan ini disampaikan
sebagai berikut :
1. Memberikan pengecualian ketentuan tata niaga impor kepada :

a. Nama Importir : BINTANG MONO INDONESIA

b. NPWP Importir : 02.739.806.4-416.000
c. Alamat Importir : MAHKOTA SIMPRUG BLOK A 13 NO 9 PANINGGILAN UTARA
CILEDUG, KOTA TANGERANG, BANTEN

d. Pihak yang bisa : SYAIFUL HIDAYAT, Tel. 62 217306932, email :

dihubungi syaiful.hidayat@ptbintangmono.com
2. Rincian jumlah dan jenis barang terlampir.
3. Izin tersebut diatas diberikan berdasarkan Keputusan PresidenNomor 9 tahun
2020 tentang perubahan atas Keputusan Presiden Nomor 7 Tahun 2020 dan
Standar Operasional Prosedur Bersama antara Direktorat Jenderal Bea dan
Cukai dan Badan Nasional Penanggulangan Bencana Nomor 01/BNPB/2020 dan
Nomor KEP-113/BC/2020.
Demikian disampaikan untuk dilaksanakan

Kepala Biro Hukum, Organisasi dan Kerjasama

Zahermann Muabezi

Tembusan:
1. Kepala BNPB (sebagai laporan);
2. Sekretaris Utama BNPB (sebagai laporan);
3. Direktur Jenderal Bea dan Cukai,Kementerian Keuangan;
4. Direktur Jenderal Farmasi dan Alat Kesehatan, Kementerian Kesehatan;
5. Direktur Penilaian Alat Kesehatan dan PKRT, Kementerian Kesehatan;
6. Direktur Registrasi Obat, BPOM;
7. Direktur Fasilitas Kepabeanan;
8. Direktur Teknis Kepabeanan;
9. Direktur Impor, Kementerian Perdagangan
Rekomendasi ini diberikan dan ditandasahkan secara elektronik, tidak diperlukan tanda tangan dan cap basah dalam bentuk hardcopy.
 Lampiran
Nomor : B-907893/BNPB/HOKS/HK.10.01/05/2020
Tanggal : 26 Mei 2020

Data Rincian Barang

1. Negara Asal : CHINA

2. Pelabuhan : Soekarno-Hatta Apt/Jakarta
3. Invoice / BL-AWB : 20DF043SCL / 20DF043SCL
4. Packing List : 20DF043SCL
5. Nama dan jumlah barang :
No Uraian Jumlah Perkiraan Harga
1 HEALGEN COVID 19 IgG IgM RAPID TEST 150,000 piece
CASSETTE
Rekomendasi ini diberikan dan ditandasahkan secara elektronik, tidak diperlukan tanda tangan dan cap basah dalam bentuk hardcopy.
 KEMENTERIAN KEUANGAN REPUBLIK INDONESIA
SALINAN
KEPUTUSAN MENTERI KEUANGAN REPUBLIK INDONESIA
NOMOR KM-2147/KPU.03/2020

TENTANG
PEMBERIAN FASILITAS KEPABEANAN DAN/ATAU CUKAI SERTA PERPAJAKAN ATAS IMPOR BARANG
UNTUK KEPERLUAN PENANGANAN PANDEMI CORONA VIRUS DISEASE (COVID-19)
KEPADA BINTANG MONO INDONESIA

MENTERI KEUANGAN REPUBLIK INDONESIA,

Menimbang : a. bahwa sesuai dengan hasil penelitian terhadap surat permohonan Bintang
Mono Indonesia Nomor COV-00014770-942 tanggal 20 Mei 2020, diperoleh
kesimpulan bahwa permohonan pemberian fasilitas kepabeanan dan/atau
cukai serta perpajakan atas impor barang untuk keperluan penanganan
pandemi Corona Virus Disease 2019 (COVID-19) telah memenuhi syarat
untuk dapat diberikan persetujuan;
b. bahwa berdasarkan pertimbangan sebagaimana dimaksud dalam huruf a,
perlu menetapkan Keputusan Menteri Keuangan tentang Pemberian Fasilitas
Kepabeanan dan/atau Cukai serta Perpajakan atas Impor Barang untuk
Keperluan Penanganan Pandemi Corona Virus Disease 2019 (COVID-19)
Kepada Bintang Mono Indonesia;
Mengingat : Peraturan Menteri Keuangan Nomor 34/PMK.04/2020 tentang Pemberian Fasilitas
Kepabeanan dan/atau Cukai serta Perpajakan atas Impor Barang untuk Keperluan
Penanganan Pandemi Corona Virus Diseases 2019 (COVID-19);
Memperhatikan : 1. Keputusan Presiden Nomor 7 Tahun 2020 tentang Gugus Tugas Percepatan
Penanganan Corona Virus Disease 2019 (COVID-19) sebagaimana telah
diubah dengan Keputusan Presiden Nomor 9 Tahun 2020;
2. Standar Operasional Prosedur Bersama Antara Direktorat Jenderal Bea dan
Cukai Dan Badan Nasional Penanggulangan Bencana Nomor Nomor
01/BNPB/2020 dan Nomor KEP-113/BC/2020 tanggal 20 Maret 2020;
3. Keputusan Direktur Jenderal Bea dan Cukai Nomor KEP-114/BC/2020 tentang
Pembentukan Satuan Tugas Penanganan Corona Virus Disease 2019
(COVID-19) dan Percepatan Pelayanan Impor Barang untuk Penanggulangan
Corona Virus Disease 2019 (COVID-19) di Lingkungan Direktorat Jenderal
Bea dan Cukai;
4. Nota Dinas Direktur Jenderal Bea dan Cukai Nomor ND-252/BC/2020 tanggal
23 Maret 2020 tentang Percepatan Pelayanan Kepabeanan atas Pemasukan
dan Pengeluaran Barang untuk Penanganan Virus Corona (COVID-19);

MEMUTUSKAN:

Menetapkan : KEPUTUSAN MENTERI KEUANGAN TENTANG PEMBERIAN FASILITAS

KEPABEANAN DAN/ATAU CUKAI SERTA PERPAJAKAN ATAS IMPOR BARANG
UNTUK KEPERLUAN PENANGANAN PANDEMI CORONA VIRUS DISEASE
(COVID-19) KEPADA BINTANG MONO INDONESIA.
PERTAMA : Memberikan fasilitas kepabeanan dan/atau cukai serta perpajakan atas impor
barang untuk keperluan penanganan pandemi Corona Virus Disease 2019 (COVID-
19) kepada Bintang Mono Indonesia, yang diimpor oleh:
a. Nama : Bintang Mono Indonesia
b. NPWP : 027398064416000
c. Alamat : Mahkota Simprug Blok A 13 No 9 Paninggilan Utara Ciledug

dengan rincian jumlah barang, uraian jenis barang, perkiraan harga, negara asal,
dan pelabuhan tempat pemasukan tercantum dalam lampiran yang merupakan
bagian tidak terpisahkan dari Keputusan Menteri ini.

Salinan SKMK ini ditandatangani secara elektronik, dapat digunakan untuk proses pengeluaran barang impor. Asli Salinan SKMK dibuat
menyusul sesuai peraturan perundang-undangan.
 KEDUA : Fasilitas kepabeanan dan/atau cukai serta perpajakan sebagaimana dimaksud
dalam Diktum PERTAMA berupa:
a. pembebasan bea masuk dan/atau cukai;
b. tidak dipungut Pajak Pertambahan Nilai atau Pajak Pertambahan Nilai dan
Pajak Penjualan atas Barang Mewah; dan
c. dibebaskan dari pemungutan Pajak Penghasilan Pasal 22.
KETIGA : Pelaksanaan pengimporan barang sebagaimana dimaksud dalam Diktum PERTAMA
harus memenuhi ketentuan di bidang impor.
KEEMPAT : Fasilitas kepabeanan dan/atau cukai serta perpajakan ini diberikan dengan
ketentuan barang sebagaimana dimaksud dalam Diktum PERTAMA akan digunakan
Untuk Keperluan Penanggulangan Covid-19.
KELIMA : Menunjuk Cengkareng / Soekarno Hatta (U) sebagai tempat
pemasukan/pengeluaran serta Kantor Pelayanan Utama Bea Dan Cukai Tipe C
Soekarno-Hatta sebagai kantor pabean tempat penyelesaian kewajiban pabean atas
barang impor sebagaimana dimaksud dalam Diktum PERTAMA.
KEENAM : Pemberian fasilitas kepabeanan dan/atau cukai serta perpajakan ini sewaktu-waktu
dapat dilakukan pemeriksaan oleh Direktorat Jenderal Bea dan Cukai.
KETUJUH : Jangka waktu pengimporan atas barang sebagaimana dimaksud dalam Diktum
PERTAMA diberikan sampai berakhirnya masa penanganan pandemi Corona Virus
Disease 2019 (COVID-19) yang ditetapkan oleh Badan Nasional Penanggulangan
Bencana.
KEDELAPAN : Dalam hal terjadi penyalahgunaan barang sebagaimana dimaksud dalam Diktum
PERTAMA, pemberian fasilitas kepabeanan dan/atau cukai serta perpajakan ini
dicabut dan dikenakan sanksi sebagaimana diatur dalam Peraturan Menteri
Keuangan Nomor 34/PMK.04/2020 tentang Pemberian Fasilitas Kepabeanan
dan/atau Cukai serta Perpajakan atas Impor Barang untuk Keperluan Penanganan
Pandemi Corona Virus Disease 2019 (COVID-19).
KESEMBILAN : Keputusan Menteri ini mulai berlaku pada tanggal ditetapkan.
Salinan Keputusan Menteri ini disampaikan kepada:
1. Menteri Keuangan;
2. Direktur Jenderal Bea dan Cukai;
3. Direktur Jenderal Pajak;
4. Direktur Fasilitas Kepabeanan;
5. Bintang Mono Indonesia

Ditetapkan di Tangerang
Salinan sesuai dengan aslinya pada tanggal 28 Mei 2020
Kepala Bidang Pelayanan Dan Fasilitas
Pabean Dan Cukai I Kantor Pelayanan Utama a.n. MENTERI KEUANGAN REPUBLIK INDONESIA
Bea Dan Cukai Tipe C Soekarno-Hatta KEPALA KANTOR PELAYANAN UTAMA BEA
u.b DAN CUKAI TIPE C SOEKARNO-HATTA,
Kepala Seksi Fasilitas Pabean Dan Cukai Ii
Bidang Pelayanan Dan Fasilitas Pabean Dan ttd.
Cukai I Kantor Pelayanan Utama Bea Dan
Cukai Tipe C Soekarno-Hatta,
FINARI MANAN, S.E., M.M.

Vincentius Istiko Murtiadji

Salinan SKMK ini ditandatangani secara elektronik, dapat digunakan untuk proses pengeluaran barang impor. Asli Salinan SKMK dibuat
menyusul sesuai peraturan perundang-undangan.
 Lampiran Keputusan Menteri
Keuangan Republik Indonesia
Nomor : KM-2147/KPU.03/2020
Tanggal : 28 Mei 2020

DAFTAR BARANG YANG MENDAPATKAN FASILITAS KEPABEANAN DAN/ATAU CUKAI

SERTA PERPAJAKAN ATAS IMPOR BARANG UNTUK KEPERLUAN PENANGANAN
PANDEMI CORONA VIRUS DISEASE (COVID-19)

Importir
a. Nama : Bintang Mono Indonesia
b. NPWP : 027398064416000
c. Alamat : Mahkota Simprug Blok A 13 No 9 Paninggilan Utara Ciledug

TEMPAT
JUMLAH SATUAN PERKIRAAN
NO. URAIAN JENIS BARANG VALUTA NEGARA ASAL PEMASUKAN/PE
BARANG BARANG HARGA
NGELUARAN

1. Healgen Covid 19 Igg Igm 150,000 Piece USD China Cengkareng /

Rapid Test Cassette Soekarno Hatta
(U)
TOTAL

Ditetapkan di Tangerang
Salinan sesuai dengan aslinya pada tanggal 28 Mei 2020
Kepala Bidang Pelayanan Dan Fasilitas a.n. MENTERI KEUANGAN REPUBLIK INDONESIA
Pabean Dan Cukai I Kantor Pelayanan Utama KEPALA KANTOR PELAYANAN UTAMA BEA
Bea Dan Cukai Tipe C Soekarno-Hatta DAN CUKAI TIPE C SOEKARNO-HATTA,
u.b
Kepala Seksi Fasilitas Pabean Dan Cukai Ii
Bidang Pelayanan Dan Fasilitas Pabean Dan ttd.
Cukai I Kantor Pelayanan Utama Bea Dan
Cukai Tipe C Soekarno-Hatta, FINARI MANAN, S.E., M.M.

Vincentius Istiko Murtiadji

Salinan SKMK ini ditandatangani secara elektronik, dapat digunakan untuk proses pengeluaran barang impor. Asli Salinan SKMK dibuat
menyusul sesuai peraturan perundang-undangan.
 PERHIMPUNAN DOKTER SPESIALIS
PATOLOGI KLINIK DAN KEDOKTERAN LABORATORIUM INDONESIA
(PDS PatKLIn)
Sekretariat:
Jl. Lontar Raya No.5 RT.002/05 Menteng Atas-Sahardjo Jakarta Selatan - 12960
Telp. 021-8308195, Fax: (021) 8308295
email: pppatklin@yahoo.com
www.pdspatklin.or.id

RAPID TEST SEROLOGI COVID-19 YANG SUDAH TERDAFTAR DI FDA

NEGARA
(NATIONAL REGULATORY AUTHORITIES IN IMDRF)
(SUMBER: WHO 08 APRIL 2020)
PDS PatKLIn, UPDATE TGL 20 APRIL 2020 JAM 14.00

A. FDA AMERIKA SERIKAT

1. Cellex Inc. USA; qSARS-CoV-2 IgG/IgM Rapid Test (1 April 2020)
2. DPP® COVID-19 IgM/IgG System; CHEMBIO DIAGNOSTICS BRAZIL LTDA.
(14 April 2020)
3. COVID-19 ELISA IgG Antibody Test; Mount Sinai Laboratory Center for Clinical
Laboratories. (15 April 2020)

B. AUSTRALIA [THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

(ARTG) 17 April 2020]
1. Wantai SARS-CoV-2 Ab Rapid Test kit; Beijing Wantai Biologicalpharmacy
Enterprise Co Ltd (China) (01-Jan-20)
2. OnSite COVID-19 IgG/IgM Rapid Test; CTK Biotech Inc (USA) (19-Mar-20)
3. VivaDiag™ COVID-19 IgM/IgG Rapid Test; VivaCheck Biotech (Hangzhou)
Co Ltd (China) (20-Mar-20)
4. 2019-n-CoV IgG/IgM Rapid Test Cassette; Hangzhou Alltest Biotech Co Ltd
(China) (23-Mar-20)
5. SARS-CoV-2 Antibody Test (Lateral Flow Method); Guangzhou Wondfo
Biotech Co Ltd (China) (25-Mar-20)
6. COVID-19 IgG/IgM Rapid Test Cassette; Hangzhou Clongene Biotech Co Ltd
(China) (26-Mar-20)
7. VivaDiag™ COVID-19 IgM/IgG Rapid Test; VivaChek Biotech (Hangzhou) Co
Ltd (China) (26-Mar-20)
8. Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit; Cellex Inc (United
States Of America) (31-Mar-20)
9. SARS-CoV-2 IgM/IgG Antibody Rapid Test; Qingdao Hightop Biotech Co Ltd
(China) (31-Mar-20)
10. COVID-19 IgG/IgM Rapid Test Cassette; Zhejiang Orient Gene Biotech Co
Ltd (China) (01-Apr-20)

Halaman 1 dari 5
 PERHIMPUNAN DOKTER SPESIALIS
PATOLOGI KLINIK DAN KEDOKTERAN LABORATORIUM INDONESIA
(PDS PatKLIn)
Sekretariat:
Jl. Lontar Raya No.5 RT.002/05 Menteng Atas-Sahardjo Jakarta Selatan - 12960
Telp. 021-8308195, Fax: (021) 8308295
email: pppatklin@yahoo.com
www.pdspatklin.or.id

11. 2019-nCoV Ab Test (Colloidal Gold); Innovita (Tangshan) Biological

Technology Co Ltd (China) (04-Apr-20)
12. COVID-19 IgG/IgM Rapid Test Cassette; Hangzhou Clongene Biotech Co Ltd
(China) (04-Apr-20)
13. COVID-19 IgG/IgM Rapid Test Cassette; Hangzhou Biotest Biotech Co Ltd
(China) (04-Apr-20)
14. COVID-19 IgG/IgM Rapid Test Cassette; Hangzhou Clongene Biotech Co Ltd
(China) (06-Apr-20)
15. Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold); Hangzhou Laihe Biotech Co Ltd (China) (06-Apr-20)
16. VivaDiag™ COVID-19 IgM/IgG Rapid Test; VivaChek Biotech (Hangzhou) Co
Ltd (China) (06-Apr-20)
17. SARS-CoV-2 IgM/lgG Antibody Rapid Test; Qingdao Hightop Biotech Co Ltd
(China) (07-Apr-20)
18. 2019-nCoV Ab Test (Colloidal Gold); Innovita (Tangshan) Biological
Technology Co Ltd (China) (08-Apr-20)
19. SARS-CoV-2 Antibody Test (Lateral Flow Method); Guangzhou Wondfo
Biotech Co Ltd (China) (09-Apr-20)
20. 2019-nCoV Ab Test (Colloidal Gold); Innovita (Tangshan) Biological
Technology Co Ltd (China) (11-Apr-20)
21. COVID-19 IgG/IgM Rapid Test Cassette; Zhejiang Orient Gene Biotech Co
Ltd (China) (14-Apr-20)
22. 2019-nCov Ab Test (Colloidal Gold); Innovita (Tangshan) Biological
Technology Co Ltd (China) (16-Apr-20)
23. 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device; Hangzhou Realy Tech Co
Ltd (China) (16-Apr-20)
24. SARS-CoV-2 Antibody Test (Lateral Flow Method); Guangzhou Wondfo
Biotech Co Ltd (China) (17-Apr-20)

C. SINGAPORE [THE HEALTH SCIENCES AUTHORITY (HAS) SINGAPURA]

1. VivaCheck Biotech Co., Ltd., China; VivaDiag COVID-19 IgM/IgG Rapid Test
(20 Maret 2020)
2. Nanjing Vazyme Medical Technology Co., Ltd., China; 2019-NCOV IgG/IgM
Diagnostic Kit (20 Maret 2020)
3. Guangzhou Wondfo Biotech Co., Ltd., China; Wondfo SARS-CoV-2 Antibody
Test (9 April 2020)

Halaman 2 dari 5
 PERHIMPUNAN DOKTER SPESIALIS
PATOLOGI KLINIK DAN KEDOKTERAN LABORATORIUM INDONESIA
(PDS PatKLIn)
Sekretariat:
Jl. Lontar Raya No.5 RT.002/05 Menteng Atas-Sahardjo Jakarta Selatan - 12960
Telp. 021-8308195, Fax: (021) 8308295
email: pppatklin@yahoo.com
www.pdspatklin.or.id

4. Camtech Diagnostics Pte., Ltd., Singapore; Camtech COVID-19 IgM/IgG (9

April 2020)

D. CHINA (NMPA APPROVED, 2 April 2020)

1. Guangzhou Wondfo Biotech Co., Ltd., China; Wondfo SARS-CoV-2 Antibody
Test
2. Innovita Biological Technology, China; 2019-NCOV AB Test
3. Bioscience (Chongqing) Diagnostic Technology Co., Ltd.; IgM Antibody test kit
for novel coronavirus 2019-nCoV (magnetic particle-based chemiluminescence
immunoassay)
4. Bioscience (Chongqing) Diagnostic Technology Co., Ltd.; IgG Antibody test kit
for novel coronavirus 2019-nCoV (magnetic particle-based chemiluminescence
immunoassay)
5. Xiamen Innodx Biotech Co., Ltd.; Antibody test kit for novel coronavirus 2019-
nCoV (chemiluminescence microparticle immunoassay)
6. Guangdong Hecin Biotech Co., Ltd., China; Novel Coronavirus (2019-nCoV-2)
IgM Antibody Test
7. Nanjing Vazyme Medical Technology Co., Ltd., China; 2019-NCOV IgG/IgM
Diagnostic Kit
8. Zhuhai Livzon Diagnostic, Inc., China; Diagnostic Kit for IgM/IgG Antibody to
Coronavirus (SARS-CoV-2)

E. BRASIL
1. AFIAS COVID-19 Ab; BODITECH MED INC (16/04/20)
2. COVID-19 IgG/IgM LF; ADVAGEN BIOTECH LTDA (03/04/20)
3. BasePoint COVID-19 IgG/IgM; GUANGZHOU WONDFO BIOTECH CO., LTD
(16/04/20)
4. Teste Rápido OnSite™ COVID-19 IgG/IgM Rapid Test; BEIJING GENESEE
BIOTECH, INC (03/04/20)
5. Celer One Step COVID-2019 Test; Guangzhou Wondfo Biotech Co., Ltd.
(24/03/20)
6. COVID-19 IgG/IgM; QINGDAO HIGHTOP BIOTECH CO., LTD. (03/04/20)
7. DPP® COVID-19 IgM/IgG System; CHEMBIO DIAGNOSTICS BRAZIL LTDA.
(25/03/20)
8. COVID-19 igG/IgM test; HUMASIS CO LTD (09/04/20)

Halaman 3 dari 5
 PERHIMPUNAN DOKTER SPESIALIS
PATOLOGI KLINIK DAN KEDOKTERAN LABORATORIUM INDONESIA
(PDS PatKLIn)
Sekretariat:
Jl. Lontar Raya No.5 RT.002/05 Menteng Atas-Sahardjo Jakarta Selatan - 12960
Telp. 021-8308195, Fax: (021) 8308295
email: pppatklin@yahoo.com
www.pdspatklin.or.id

9. CORONAVÍRUS RAPID TEST; GUANGZHOU WONDFO BIOTECH CO.,

LTD (24/03/20)
10. CORONAVÍRUS IgG/IgM (COVID-19); EBRAM PRODUTOS
LABORATORIAIS LTDA (20/03/20)
11. ECO F COVID-19 Ag; Eco Diagnostica Ltda (24/03/20)
12. COVID-19 IgG/IgM ECO Teste; Eco Diagnostica Ltda (24/03/2020)
13. COVID-19 Ag ECO Teste Eco Diagnostica Ltda (24/03/2020)
14. TR DPP® COVID-19 IGM/IGG; Bio-Manguinhos (16/04/20)
15. Anti COVID-19 IgG/IgM Rapid Test; LABTEST DIAGNOSTICA S/A (24/03/20)
16. LUMIRATEK COVID-19 (IgG/IgM); HANGZHOU BIOTEST BIOTECH CO.,
LTD. (25/03/20)
17. BIOSYNEX COVID-19 BSS; BIOSYNEX SA (16/04/20)
18. MedTeste Coronavírus (COVID-19) IgG/IgM (TESTE RAPIDO); HANGZHOU
BIOTEST BIOTECH CO., LTD. (24/03/2020)
19. Teste Rápido Covid-19 15 minutos Nutriex; HANGZHOU SINGCLEAN
MEDICAL PRODUCTS CO., LTD (16/04/20)
20. Família Teste Rápido em Cassete 2019-nCoV IgG/IgM (sangue
total/soro/plasma); ACRO BIOTECH INC. (24/03/20)
21. Família AllTest COVID-19 IgG/IgM Teste Rápido (Sangue total/
Soro/Plasma); HANGZHOU ALLTEST BIOTECH CO., LTD. (03/04/20)
22. COVID-19 IgG/IgM BIO; QUIBASA QUÍMICA BÁSICA LTDA (09/04/20)
23. QuickProfile COVID-19 IgG/IgM Combo Test Card; LUMIQUICK
DIAGNOSTICS, INC. (16/04/20)
24. Smart Test Covid-19 Vyttra; VYTTRA DIAGNOSTICOS IMPORTACAO E
EXPORTACAO S.A. (31/03/20)

F. FDA PHILIPPHINES (16 April 2020, 4:00PM)

1. NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT; Biolidics Limited.
2. NOVEL CORONAVIRUS (2019- NCOV) IgM/IgG ANTIBODY DETECTION
KIT (COLLOIDAL GOLD METHOD); Nanjing Vazyme Medical Technology
Co., Ltd
3. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-
CoV-2) (COLLOIDAL GOLD); Zhuhai Livzon Diagnostic Inc.
4. 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD); Innovita (Tangshan)
Biological Technology Co., Ltd.

Halaman 4 dari 5
 PERHIMPUNAN DOKTER SPESIALIS
PATOLOGI KLINIK DAN KEDOKTERAN LABORATORIUM INDONESIA
(PDS PatKLIn)
Sekretariat:
Jl. Lontar Raya No.5 RT.002/05 Menteng Atas-Sahardjo Jakarta Selatan - 12960
Telp. 021-8308195, Fax: (021) 8308295
email: pppatklin@yahoo.com
www.pdspatklin.or.id

5. SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD); Guangzhou

Wondfo Biotech Co., Ltd.
6. WANTAI SARS- CoV Ab RAPID TEST KIT; Beijing Wantai Biological
Pharmacy Enterprise Co., Ltd.
7. 2019 n-CoV IgG/IgM RAPID TEST CASSETTE; Hangzhou Alltest Biotech
Co., Ltd.
8. OnSite COVID-19 IgG/IgM Rapid Test; CTK Biotech, Inc.
9. HIGHTOP SARS-CoV-2 IgM/IgG ANTIBODY RAPID TEST; Qingdao Hightop
Biotech Co., Ltd.
10. Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test; Cellex, Inc.,
11. COVID-19 IgG/IgM RAPID TEST KIT; Hangzhou Biotest Biotech Co., Ltd.
12. DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgM
ANTIBODY (MAGNETIC PARTICLE CLIA); Bioscience (Chongqing)
Diagnostic Technology Co., Ltd
13. DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgG
ANTIBODY (MAGNETIC PARTICLE CLIA); Bioscience (Chongqing)
Diagnostic Technology Co., Ltd
14. COVID-19 IgG/IgM Rapid Test Cassette; Healgen Scientific Limited
15. COVID-19 IgG/IgM RAPID TEST CASSETTE; Zhejiang Orient Gene Biotech
Co., Ltd
16. BIOLIDICS 2019-nCoV IgG/IgM DETECTION KIT; Biolidics Limited.

G. KOREA (IVD CERTIFIED)

1. STANDARDTM Q COVID-19 IgM/IgG Duo Test; SD Biosensor
2. STANDARDTM Q COVID-19 Ag Test; SD Biosensor
3. STANDARDTM F COVID-19 Ag FIA; SD Biosensor
4. SGTi-flex COVID-19 IgM/IgG; Sugentech
5. SGTi-flex COVID-19 IgM; Sugentech
6. SGTi-flex COVID-19 IgG; Sugentech
7. GenBody COVID-19 IgM/IgG; GenBody
8. Humasis COVID-19 IgG/IgM Test; Humasis

Jakarta, 22 April 2020 jam 14.30

Ketua Umum Sekjen

Halaman 5 dari 5
Prof. DR. Dr. Aryati, MS., Sp.PK(K) Dr. Marina Ludong., Sp.PK