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Total Estrogens ELISA

FDA UDI

Class I (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Total Estrogens ELISA FDA UDI
Generic Name
Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
For the quantitative determination of total estrogens by an enzyme immunoassay in human serum. FDA UDI
Model / Reference
11-ESGTHU-E01 FDA UDI
Description
For the quantitative determination of total estrogens by an enzyme immunoassay in human serum. FDA UDI

Identifiers

Catalog Number
11-ESGTHU-E01 FDA UDI
Primary DI / UDI-DI
B24211ESGTHUE010 FDA UDI
FDA Product Code
JMD FDA UDI
GMDN Term
Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1275 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: Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA)

Total Estrogens ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total estrogen (oestrogen) 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 5cf1e052-0aa8-432d-9d92-bebd650b57ba 36 fields · synced May 30, 2026