Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- SARS-CoV-2 IgG Reagent Kit 100 Tests FDA UDI
- Model / Reference
- 06R8620 FDA UDI
- Description
- SARS-CoV-2 IgG Reagent Kit 100 Tests FDA UDI
Identifiers
- Catalog Number
- 06R8620 FDA UDI
- Primary DI / UDI-DI
- 00380740191832 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Architect by Abbott Laboratories, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.
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- Anti-SARS-CoV-2 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · N
- IDS SARS-COV-2 IgG — Immunodiagnostic Systems , Ltd. · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 3c6bc3f7-e7ca-4b19-a1a7-a4d322f91210 36 fields · synced Jun 8, 2026