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KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA UDI

Class II (US FDA UDI)

by Kronus, Inc.

Identity

Trade Name
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit FDA UDI
Generic Name
Thyrosin phosphatase antibody (anti-IA2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum FDA UDI
Model / Reference
KR7755 FDA UDI
Description
An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum FDA UDI

Identifiers

Catalog Number
KR7755 FDA UDI
Primary DI / UDI-DI
B126KR77550 FDA UDI
510(k) Number
K171731 FDA UDI
K220085 FDA UDI
FDA Product Code
OIF FDA UDI
GMDN Term
Thyrosin phosphatase antibody (anti-IA2) 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

No

FDA UDI

Category: Thyrosin phosphatase antibody (anti-IA2) IVD, kit, enzyme immunoassay (EIA)

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA 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 b6397fbe-6c83-4e36-b7d5-80f0ce8fa373 36 fields · synced Jun 8, 2026