Identity
- Trade Name
- PROG ELISA FDA UDI
- Generic Name
- Progesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- PROG ELISA FDA UDI
- Model / Reference
- KAP1451 FDA UDI
- Description
- PROG ELISA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05400569000162 FDA UDI
- FDA Product Code
- JLS FDA UDI
- GMDN Term
- Progesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Progesterone IVD, kit, enzyme immunoassay (EIA)
Prog Elisa by Diasource Immunoassays, S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Progesterone IVD, kit, enzyme immunoassay (EIA).
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- Pantex P637SP — Pantex
- Progesterone AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- Salivary Progesterone ELISA — DRG International, Inc. · Class I
- Pantex — Pantex · Class I
- Pantex P637SP — Pantex
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
- Diasource Immunoassays, S.A.
Sources (1)
- FDA UDI e095f962-9d46-4aa8-8436-6a8ebc0017bb 33 fields · synced Jun 1, 2026