Identity
- Trade Name
- 17-alpha Hydroxy Progesterone ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (EDTA, heparin, or citrate). For in vitro diagnostic use. FDA UDI
- Model / Reference
- 20-17OHU-E01 FDA UDI
- Description
- The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (EDTA, heparin, or citrate). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 20-17OHU-E01 FDA UDI
- Primary DI / UDI-DI
- B2422017OHUE010 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-alpha Hydroxy Progesterone ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA).
- 17OHP AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- N-17-OHP AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- Salivary 17-OH Progesterone ELISA — DRG International, Inc. · Class I
- 17OHP-SI AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- 17-OH Progesterone ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Salivary 17-OH Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- N-17-OHP AccuBind ELISA Test System - 960 Wells — MONOBIND, INC. · Class I
- SPOTCHECK — ASTORIA-PACIFIC, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI 408bf3fc-7170-4b40-9e28-7c6ea2d19918 36 fields · synced Jun 8, 2026