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Salimetrics

FDA UDI

Class I (US FDA UDI)

by Salimetrics Llc.

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 (25-pack) FDA UDI
Model / Reference
N/A FDA UDI
Description
High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit (25-pack) FDA UDI

Identifiers

Catalog Number
1-4702-25 FDA UDI
Primary DI / UDI-DI
00859410006061 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).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Salimetrics Llc.

Sources (1)

  • FDA UDI edf17e82-7914-4b86-87c8-cc69c2ef42ac 35 fields · synced May 30, 2026