Abbott Rapid Diagnostics Jena GmbH

2. Information Supplied by the Manufacturer

2.1. Labels
Test Device Labelling

Figure 2-1: Test device labels (front and back side)

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Kit Labelling

Figure 2-2: Overview: Complete Kit Packaging for Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-T402 incl. printed labeling
information (overview). The following Figures 2-3 to 2-7 show enlarged sections of this box label so that the information is readible

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Figure 2-3: Kit Packaging for Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-T402 incl. printed labeling information (product
name and symbols).

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Figure 2-4: Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-T402 specific label information: Kit contents (in EN, DE, ES)

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Figure 2-5: Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-T402 specific label information: Kit contents (in FR, IT, PT)

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Figure 2-6: Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-T402
specific label information: Reference number, lot number, expiry date

Figure 2-7: Figure 2-3: Panbio™ COVID-19 IgG/IgM Rapid Test Device Ref. ICO-
T402 specific label information (kit contents): Manufacturer name and address
and label information (incl. storage conditions, overall content number of
included tests, symbols)

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The following GTIN code has been procured from GS1 Germany for this product:
Product Product GTIN Barcode
Reference (former EAN-
Number 13)
Panbio™ COVID-19 ICO-T402 4051892001107
IgG/IgM Rapid Test
Device (Fingerstick
Whole Blood/ Venous
Whole Blood/
Serum/Plasma)
Note: EAN-13 code on the shipment box containing 72 kits (each with 25 tests) is as
follows: 4051892001114. EAN-13 code on the shipment box containing 60 kits (each
with 25 tests) is as follows: 4051892001121.

Accessory Labelling
2.1.3.1. Specimen Droppers
Specimen Droppers are packaged in a plastic zip bag. As this kit only contains
one type of Specimen Dropper (in addition to the labeled pouched test device
and the labeled buffer), there is no separate label provided for the droppers.

2.1.3.2. Buffer

Figure 2-8: Buffer label

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2.2. Instructions for Use

Currently, the Instructions for Use are available in a booklet including the
following languages: English, German, French, Spanish, Portuguese and
Italian. It will be translated into the languages required by the individual target
countries prior to launch in these countries and in agreement with applicable
regulations.

In addition to the IFU, a non-verbal Quick Reference Guide (QRG) describing

the capillary blood collection by finger prick and subsequent sample
application to the device, testing and result interpretation is available.

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