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FDA Advisory No.2021-2094 || List

of COVID-19 Test Kits with FDA
Special Certification and
Performance Validation Conducted
and/or Recommended by the
Research Institute for Tropical
Medicine (RITM)
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On 23 March 2021, the Food and Drug Administration

(FDA) issued FDA Memorandum No. 2021-009 entitled
“Minimum Performance Requirements for COVID-19
Test Kits Used for SARS-CoV-2 Infection”. This issuance
provides that compliance to the minimum performance
requirements for sensitivity and specificity based on the
performance validation conducted by the Research
Institute for Tropical Medicine (RITM) shall be required
prior to the issuance of Special Certification for all
COVID-19 test kits.

In view of the above and in the interest of protecting

public health and safety, the FDA hereby announces the
list of COVID-19 test kits that have passed the
performance validation conducted and/or
recommended by the RITM and were issued with FDA
Special Certification in accordance with the
abovementioned FDA Memorandum as of 2 August
2021.

List of Approved PCR Based Test Kits for

Commercial Use

Product Name & Name of Specimen RITM RITM

Name Address of Importer/ Validated Validated
Manufacturer Distributor Result Result
Sensitivity Specificity

1. SARS-CoV- Maccura Assurance Oropharyngeal 96.23% 100%

2 Biotechnology Controls swabs and
Fluorescent Co., Ltd. Technologies Sputum
PCR Kit Co., Inc.
16# Baichuan
Road, High-
Tech Zone,
611731
Chengdu,
People’s
Republic of
China

2. BioFire BioFire Biomerieux Nasopharyngeal 100% 100%

Respiratory Diagnostic, Philippines swab
Panel 2.1 LCC. Corporation
(RP2.1)
515 Colorow
Drive, Salt
Lake City,
Utah, 84108,
USA

3. i-DENSY ARKRAY ARKRAY Nasopharyngeal 100% 100%

PACK INDUSTRY Industry Inc swab
UNIVERSAL INC.
REAGENT
Lot 22 Phase
(i-DENSY 1A, First
PACK Philippine
UNIVERSAL Industrial
SARS-CoV- Park, Brgy.
2 Sta.
DETECTION Anastacia,
SYSTEM) Sto. Tomas,
Batangas

4. SARS-CoV- ARKRAY ARKRAY Nasopharyngeal 100% 100%

2 INDUSTRY Industry Inc swab
DETECTION INC.
PRIMER
PROBE SET Lot 22 Phase
REAGENT 1A, First
Philippine
(i-DENSY Industrial
PACK Park, Brgy.
UNIVERSAL Sta.
SARS-CoV- Anastacia,
2 Sto. Tomas,
DETECTION Batangas
SYSTEM)

5. SARS-COV- Zybio Inc.- Sahar Nasal/throat 100% 100%

2 Nucleic Floor 1 to International swabs
Acid Floor 5, Trading Inc
Detection Building 30,
Kit (PCR- No.6 of
Fluorescent Taikang Road,
Probe Block C of
Method) Jianqiao
Industrial
Park, Dadukou
District,
Chongqing,
China

6. Xpert Cepheid AB- Macare Nasopharyngeal, 100% 99%

Xpress Röntgenvägen Medicals, Inc oropharyngeal,
SARS-CoV- 5, 171 54 nasal, or mid-
2 Solna, turbinate swab
Sweden or nasal
wash/aspirate
specimens

List of Approved Antigen Test Kits for Commercial

Use

Product Name & Name of Specimen RITM RITM

Name Address of Importer/ Validated Validated
Manufacturer Distributor Result Result
Sensitivity Specificity

1. PanbioTM Abbot Rapid Sunfu Nasopharyngeal CT < 30 100%

Diagnostics Solutions Inc. Swab (97.83%)
COVID-19 Jena GmbH
Ag Rapid
Test Device Orlaweg 1
07743 Jena,
Germany

2. PanbioTM Abbot Sunfu Nasopharyngeal CT < 30 100%

Diagnostics Solutions Inc Swab (97.83%)
COVID-19 Korea Inc.
Ag Rapid
Test Device 65,
Borahagal-ro,
Giheung-gu,
Yongin-si,
Gyenoggi-do
17099,
Republic of
Korea

3. SOFIA 2 Quidel LABx CORP. Nasopharyngeal CT < 30 100%

SARS Corporation /Nasal Swab (92.86%)
Antigen FIA
10165
McKellar
Court, San
Diego, CA
92121 USA

4. PanbioTM Abbott Rapid Allied Hospital Nasopharyngeal CT < 30 100%

COVID-19 Diagnostics Supply swab (97.83%)
Ag Rapid Jena GmbH- International
Test Device Orlaweg 1 Corp
07743 Jena,
Germany

5. STANDARD™ SD Biosensor, Trulaboratories Nasopharyngeal CT<30 100%

Q COVID-19 Inc-C-4&5 Corporation swab 93.1%
Ag TEST KIT Floor, 16,
Deogyeong-
daero
1556beon-gil,
Yeongtong-
gu, Suwon-si,
Gyeonggi-do,
16690,
Republic of
Korea

6. PanbioTM Abbott Rapid Allied Hospital Nasal swab CT < 30 99.20%

COVID-19 Diagnostics Supply (90.5%)
Ag Rapid Jena GmbH- International
Test Device Orlaweg 1 Corp.
07743 Jena,
Germany

7. NowCheck BioNote Inc- Biologic Life Nasopharyngeal CT < 30 97.30%

COVID-19 22 Samsung Sciences swab (91.4%)
Antigen Test 1-ro-4-gil, Corp.
Hwaseong-Si,
Gyeonggido,
18449
Republic of
Korea

8. Novel Guangzhou Tradematchers, Nasopharyngeal CT < 30 100%

Coronavirus Wondfo Inc. or (92.2%)
(2019- Biotech Oropharyngeal
nCoV) Co., - swabs
Antigen Guangzhou
Detection Wondfo
Kit Biotech
(Colloidal Co., Ltd. –
Gold No. 8
Method) // Lizhishan
Wondfo Road,
2019-nCoV Science
Antigen City,
Test Luogang
(Lateral District,
flow) 510663,
Guangzhou,
P.R. China

9. Novel Guangzhou LabSolution Nasopharyngeal CT < 30 100%

Coronavirus Wondfo Technologies or (92.2%)
(2019- Biotech Inc. Oropharyngeal
nCoV) Co., - swabs
Antigen Guangzhou
Detection Wondfo
Kit Biotech
(Colloidal Co., Ltd. –
Gold No. 8
Method) // Lizhishan
Wondfo Road,
2019-nCoV Science
Antigen City,
Test Luogang
(Lateral District,
flow) 510663,
Guangzhou,
P.R. China

10. Novel Guangzhou Alcheon Nasopharyngeal CT < 30 100%

Coronavirus Wondfo Medical or (92.2%)
(2019- Biotech Corporation Oropharyngeal
nCoV) Co., - swabs
Antigen Guangzhou
Detection Wondfo
Kit Biotech
(Colloidal Co., Ltd. –
Gold No. 8
Method) // Lizhishan
Wondfo Road,
2019-nCoV Science
Antigen City,
Test Luogang
(Lateral District,
flow) 510663,
Guangzhou,
P.R. China

List of Approved Antibody Rapid Test Kits for

Commercial Use

Product Name & Name of Specimen RITM RITM

Name Address of Importer/ Validated Validated
Manufacturer Distributor Result Result
Sensitivity Specificity

1. VivaDiagTM Vivachek Philippine Whole 92.00% 99.33%

Biotech Blue Cross Blood /
COVID-19 Hangzhou Co. Biotech Serum /
IgM/IgG Ltd. Corporation Plasma
Rapid Test and
Level 2, Block Fingertip
2, 146 East Blood
Chaofeng Rd.,
Yuhang
Economy
Development
Zone,
Hangzhou,
311100,
Zhejiang
China

2. NADAL Nal Von Diagnostika Human 92.67% 100.00%

COVID-19 Minden Pilipinas, whole
IgG/IgM GmbH- Carl- Inc. blood,
Test Zeiss-Str. 12, serum or
47445 Moers, plasma
Germany

The above list shall be regularly updated. For reference,

please click the link:
https://docs.google.com/spreadsheets/d/13S12QST9RKlyX1ipUhqhmngwq3rdtbLRnDWPg8-
OSqo/edit#gid=0.

For more information and inquiries, kindly contact the

FDA – Center for Device Regulation, Radiation Health,
and Research through e-mail at cdrrhr@fda.gov.ph or
call (02) 8857-1900 loc. 8301.

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FDA Advisory 2021 - 2094 (330 kB)

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