Identity
- Trade Name
- 21-Hydroxylase Autoantibody ELISA FDA UDI
- Generic Name
- Adrenal antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI
- Model / Reference
- EIA-5955 FDA UDI
- Description
- The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI
Identifiers
- Catalog Number
- EIA-5955 FDA UDI
- Primary DI / UDI-DI
- 00840239059550 FDA UDI
- 510(k) Number
- K121046 FDA UDI
- FDA Product Code
- PCG FDA UDI
- GMDN Term
- Adrenal antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Adrenal antibody IVD, kit, enzyme immunoassay (EIA)
21-Hydroxylase Autoantibody ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- DRG International, Inc.
Sources (1)
- FDA UDI 1c50e6d6-0d84-46d1-baf2-42bb7e934fdc 37 fields · synced Jun 8, 2026