Identity
- Trade Name
- Salimetrics FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit FDA UDI
Identifiers
- Catalog Number
- 1-4702 FDA UDI
- Primary DI / UDI-DI
- 00859410006085 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1260 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: Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)
Salimetrics by Salimetrics Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA).
- Pantex P674SE — Pantex
- Pantex P674SE — Pantex
- Pantex P674SE — Pantex
- Salivary Estradiol ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Pantex P674SE — Pantex
- VIDAS® Estradiol II — BIOMERIEUX , INC. · Class I
- Salivary Estradiol HS ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Salivary Estradiol HS ELISA — DRG International, 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
- Salimetrics Llc.
Sources (1)
- FDA UDI 8fe9f37b-475a-4cdb-94cc-e6135c783b99 35 fields · synced May 30, 2026