Identity
- Trade Name
- Progesterone (17-a-OH Progesterone) FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:Hybrid-XL 17-OH Progesterone is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-OH Progesterone or 17OHP) in serum and plasma. FDA UDI
- Model / Reference
- HYE-5333 FDA UDI
- Description
- The DRG:Hybrid-XL 17-OH Progesterone is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-OH Progesterone or 17OHP) in serum and plasma. FDA UDI
Identifiers
- Catalog Number
- HYE-5333 FDA UDI
- Primary DI / UDI-DI
- 00840239053336 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
Yes
FDA UDI
Category: 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Progesterone (17-a-OH Progesterone) by DRG International, Inc. — 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
- 17OHP-SI AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- 17-OH Progesterone ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- 17-alpha Hydroxy Progesterone ELISA — American Laboratory Products Company · 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
- DRG International, Inc.
Sources (1)
- FDA UDI 94898969-4252-4bd1-888f-d64392c59843 36 fields · synced Jun 8, 2026