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E2 Elisa

FDA UDI

Class I (US FDA UDI)

by Diasource Immunoassays, S.A.

Identity

Trade Name
E2 ELISA FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
E2 ELISA FDA UDI
Model / Reference
KAP0621 FDA UDI
Description
E2 ELISA FDA UDI

Identifiers

Primary DI / UDI-DI
05400569000063 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

E2 Elisa by Diasource Immunoassays, S.A. — 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
Diasource Immunoassays, S.A.

Sources (1)

  • FDA UDI 6b66ff35-990c-4f80-a5de-ca05b37de856 33 fields · synced Jun 8, 2026