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uE3 AccuBind ELISA Test System - 192 Wells

FDA UDI

Class I (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
uE3 AccuBind ELISA Test System - 192 Wells FDA UDI
Generic Name
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
5025-300 FDA UDI

Identifiers

Catalog Number
5025-300B FDA UDI
Primary DI / UDI-DI
00816870021409 FDA UDI
FDA Product Code
CGI FDA UDI
GMDN Term
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1265 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

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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 7.75 Inch FDA UDI

Category: Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)

uE3 AccuBind ELISA Test System - 192 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA UDI 74428d1b-e180-416d-9745-8410f6690f77 36 fields · synced Jun 8, 2026