Identity
- Trade Name
- Salivary 17-OH Progesterone ELISA FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva. FDA UDI
- Model / Reference
- SLV-3140 FDA UDI
- Description
- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva. FDA UDI
Identifiers
- Catalog Number
- SLV-3140 FDA UDI
- Primary DI / UDI-DI
- 04048474031409 FDA UDI
- 510(k) Number
- K062534 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
No
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)
Salivary 17-OH Progesterone ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID
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Also classified as 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA).
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- 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
- 17-alpha Hydroxy Progesterone ELISA — American Laboratory Products Company · Class I
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- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class I
Cleared under the same submission
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 283ee163-705f-44ce-a55c-c69ae0a641a5 37 fields · synced May 30, 2026