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Kronus Glutamic Acid Decarboxylase Ria Antibody Kit

FDA UDI

Class II (US FDA UDI)

by Kronus, Inc.

Identity

Trade Name
KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT FDA UDI
Generic Name
Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay FDA UDI
Device Name
An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum. FDA UDI
Model / Reference
KR6710 FDA UDI
Description
An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum. FDA UDI

Identifiers

Catalog Number
KR6710 FDA UDI
Primary DI / UDI-DI
B126KR67100 FDA UDI
510(k) Number
K051061 FDA UDI
FDA Product Code
NWG FDA UDI
GMDN Term
Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay 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

No

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

No

FDA UDI

Category: Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay

Kronus Glutamic Acid Decarboxylase Ria Antibody Kit by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kronus, Inc.

Sources (1)

  • FDA UDI 67011a56-5c64-4e2b-910a-c43c9ced7cea 36 fields · synced May 30, 2026