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Salimetrics

FDA UDI

Class II (US FDA UDI)

by Salimetrics Llc.

Identity

Trade Name
Salimetrics FDA UDI
Generic Name
Total cortisol IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (25 pack) FDA UDI
Model / Reference
N/A FDA UDI
Description
Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (25 pack) FDA UDI

Identifiers

Catalog Number
1-3102-25 FDA UDI
Primary DI / UDI-DI
00859410006023 FDA UDI
510(k) Number
K031348 FDA UDI
FDA Product Code
NHG FDA UDI
GMDN Term
Total cortisol IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1205 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total cortisol IVD, kit, enzyme immunoassay (EIA)

Salimetrics by Salimetrics Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total cortisol IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K031348 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Salimetrics Llc.

Sources (1)

  • FDA UDI 9da85f0a-cf19-4bb7-8b43-e754200db6da 36 fields · synced May 30, 2026