Identity
- Trade Name
- 17 OH-Progesterone ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-a-OHP) in serum or plasma (EDTA, lithium heparin or citrate plasma). FDA UDI
- Model / Reference
- EIA-1292 FDA UDI
- Description
- The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-a-OHP) in serum or plasma (EDTA, lithium heparin or citrate plasma). FDA UDI
Identifiers
- Catalog Number
- EIA-1292 FDA UDI
- Primary DI / UDI-DI
- 00404847412925 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
17 OH-Progesterone 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 ebebf895-9176-4919-b997-e79e91a038fc 37 fields · synced May 30, 2026