Identity
- Trade Name
- Salimetrics FDA UDI
- Generic Name
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Salivary Insulin Elisa Kit (5-pack) FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Salivary Insulin Elisa Kit (5-pack) FDA UDI
Identifiers
- Catalog Number
- 1-4410-5 FDA UDI
- Primary DI / UDI-DI
- 00859410006276 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 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: Insulin 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 Insulin IVD, kit, enzyme immunoassay (EIA).
- Insulin AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- Insulin ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- ALPCO Ultrasensitive Insulin ELISA — American Laboratory Products Company · Class I
- Insulin AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- Insulin ELISA — DRG International, Inc. · Class I
- ALPCO Insulin ELISA Jumbo — American Laboratory Products Company · Class I
- ALPCO Insulin ELISA — American Laboratory Products Company · Class I
- ALPCO Ultrasensitive Insulin ELISA Jumbo — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salimetrics Llc.
Sources (1)
- FDA UDI cfa7b5de-af84-4498-ac2b-cdfbf7ae04af 35 fields · synced May 31, 2026