Identity
- Trade Name
- 17-OH-Progesterone ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 17-OH-Progesterone ELISA - 96 Determinations FDA UDI
- Model / Reference
- 30223011 FDA UDI
- Description
- 17-OH-Progesterone ELISA - 96 Determinations FDA UDI
Identifiers
- Catalog Number
- 30223011 FDA UDI
- Primary DI / UDI-DI
- 04049325033627 FDA UDI
- FDA Product Code
- JLX FDA UDI
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1395 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
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: 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
17-OH-Progesterone ELISA by IBL International GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manufacturer
- IBL International GmbH
Sources (1)
- FDA UDI 032627c5-a64f-4180-85f5-c7d72e9f99d2 36 fields · synced May 30, 2026