Identity
- Trade Name
- Access SARS-CoV-2 IgG II QC FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization. FDA UDI
- Model / Reference
- C69059 FDA UDI
- Description
- The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization. FDA UDI
Identifiers
- Catalog Number
- C69059 FDA UDI
- Primary DI / UDI-DI
- 15099590742768 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control 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
Yes
FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Access SARS-CoV-2 IgG II QC by Beckman Coulter, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI e8078859-2156-4fc0-9b5b-70cf01ba26d5 34 fields · synced Jun 8, 2026