Identity
- Trade Name
- Progesterone, 17-a-OH ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The DRG 17-a-OH Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of 17-a-OH Progesterone in serum. FDA UDI
- Model / Reference
- CLA-4665 FDA UDI
- Description
- The DRG 17-a-OH Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of 17-a-OH Progesterone in serum. FDA UDI
Identifiers
- Catalog Number
- CLA-4665 FDA UDI
- Primary DI / UDI-DI
- 00404847446654 FDA UDI
- FDA Product Code
- JLX FDA UDI
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1395 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Progesterone, 17-a-OH ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 1e4b4a5c-cfbf-46f8-9869-3987700cfd0e 37 fields · synced May 31, 2026