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GAD65 Ab ELISA

FDA UDI

Class II (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
GAD65 Ab ELISA FDA UDI
Generic Name
Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The GAD65 Autoantibody (GAD Ab) ELISA kit is intended for use by professional persons only, for the quantitative determination of GAD Ab in human serum. FDA UDI
Model / Reference
EIA-4087 FDA UDI
Description
The GAD65 Autoantibody (GAD Ab) ELISA kit is intended for use by professional persons only, for the quantitative determination of GAD Ab in human serum. FDA UDI

Identifiers

Catalog Number
EIA-4087 FDA UDI
Primary DI / UDI-DI
04048474040876 FDA UDI
FDA Product Code
NWG FDA UDI
GMDN Term
Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)

GAD65 Ab ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 813d4b82-48de-421e-bacb-b382ffbd90a7 36 fields · synced May 30, 2026