Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
- Device Name
- VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Calibrator FDA UDI
- Model / Reference
- 6199952 FDA UDI
- Description
- VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Calibrator FDA UDI
Identifiers
- Catalog Number
- 6199952 FDA UDI
- Primary DI / UDI-DI
- 10758750033614 FDA UDI
- 510(k) Number
- DEN210038 FDA UDI
- FDA Product Code
- QVP FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3983 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
No
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, calibrator
Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator.
- Alinity — Abbott Ireland Diagnostics · N
- Alinity — Abbott Laboratories, Inc. · N
- Access SARS-CoV-2 IgG Calibrator — Beckman Coulter, Inc. · N
- ARCHITECT — Abbott Ireland Diagnostics · N
- FastPack SARS-CoV-2 IgG — QUALIGEN INC. · N
- ARCHITECT — Abbott Laboratories, Inc. · N
- Access SARS-CoV-2 IgG II Calibrator — Beckman Coulter, Inc. · N
Cleared under the same submission
DEN210038 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI c3d3ac49-dffe-4dc2-ba84-84e2b675fb1f 36 fields · synced May 30, 2026