Identity
- Trade Name
- Salimetrics FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- High Sensitivity Salivary Estriol Enzyme Immunoassay Kit FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- High Sensitivity Salivary Estriol Enzyme Immunoassay Kit FDA UDI
Identifiers
- Catalog Number
- 1-2812 FDA UDI
- Primary DI / UDI-DI
- 00859410006153 FDA UDI
- FDA Product Code
- PEJ FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)
Salimetrics by Salimetrics Llc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA).
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- Ansh Labs Unconjugated Estriol EIA — Ansh Labs, LLC
- uE3 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- Salimetrics — SALIMETRICS LLC. · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Salimetrics Llc.
Sources (1)
- FDA UDI 4db7e71c-d30c-4e53-94a6-db9b71779663 35 fields · synced Jun 1, 2026