Identity
- Trade Name
- Salivary Progesterone HS ELISA FDA UDI
- Generic Name
- Progesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. FDA UDI
- Model / Reference
- SLV-5911 FDA UDI
- Description
- Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. FDA UDI
Identifiers
- Catalog Number
- SLV-5911 FDA UDI
- Primary DI / UDI-DI
- 00840239059116 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
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: Progesterone IVD, kit, enzyme immunoassay (EIA)
Salivary Progesterone HS ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Progesterone IVD, kit, enzyme immunoassay (EIA).
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- Pantex — Pantex · Class I
- Pantex P637SP — Pantex
- ST AIA-PACK PROG II — Tosoh Corp. · Class II
- Progesterone ELISA — American Laboratory Products Company · 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
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI cbeafd46-8c48-4b7d-b889-e017d7999ca2 36 fields · synced May 31, 2026