Identity
- Trade Name
- Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The quantitative determination of 17-hydroxyprogesterone concentration in human whole blood by a microplate enzyme immunoassay, colorimetric. FDA UDI
- Model / Reference
- EIA-1429 FDA UDI
- Description
- The quantitative determination of 17-hydroxyprogesterone concentration in human whole blood by a microplate enzyme immunoassay, colorimetric. FDA UDI
Identifiers
- Catalog Number
- EIA-1429 FDA UDI
- Primary DI / UDI-DI
- 04048474014297 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
- 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
Category: 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay
Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay.
- 17OHP AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- 17 OH Progesterone ELISA — DRG International, Inc. · Class I
- 17OHP AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Monobind AccuLite 17OHP-SI CLIA Kit - 192 Wells — MONOBIND, INC. · Class I
- 17OHP-SI AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA — DRG International, Inc. · Class I
- 17 OH-Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
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 92d09328-8acd-47ed-9188-243e00f0bfd6 36 fields · synced May 30, 2026