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Estradiol ELISA

FDA UDI

Class I (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Estradiol ELISA FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Intended for the direct quantitative determination of Estradiol by enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI
Model / Reference
11-ESTHU-E01 FDA UDI
Description
Intended for the direct quantitative determination of Estradiol by enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
11-ESTHU-E01 FDA UDI
Primary DI / UDI-DI
B24211ESTHUE010 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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)

Estradiol ELISA by American Laboratory Products Company — 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
American Laboratory Products Company

Sources (1)

  • FDA UDI c2a32042-50a7-4832-ab69-fea50ca4544c 36 fields · synced May 30, 2026