Identity
- Trade Name
- SARS-CoV-2 IgG ELISA Kit FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- SARS-CoV-2 IgG ELISA Kit FDA UDI
- Model / Reference
- K1919 FDA UDI
- Description
- SARS-CoV-2 IgG ELISA Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571113011 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) 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
No
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
No
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, enzyme immunoassay (EIA)
SARS-CoV-2 IgG ELISA Kit by Agilent Technologies 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, enzyme immunoassay (EIA).
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- SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · 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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 2f505863-84b9-4acb-8a68-acaaa3446670 36 fields · synced Jun 8, 2026