Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator FDA UDI
- Device Name
- AdviseDx SARS-CoV-2 IgM Calibrator Kit FDA UDI
- Model / Reference
- 06R9101 FDA UDI
- Description
- AdviseDx SARS-CoV-2 IgM Calibrator Kit FDA UDI
Identifiers
- Catalog Number
- 06R9101 FDA UDI
- Primary DI / UDI-DI
- 00380740192068 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator 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 M (IgM) antibody IVD, calibrator
Alinity by Abbott Ireland Diagnostics — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator.
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 Ireland Diagnostics
Sources (1)
- FDA UDI bb32e808-a64e-4f17-acdb-fdefe3e9d2bc 36 fields · synced May 30, 2026