← Back to catalogue

Kronus Insulin Autoantibody (iaa) Assay Kit

FDA UDI

Class II (US FDA UDI)

by Kronus, Inc.

Identity

Trade Name
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT FDA UDI
Generic Name
Insulin antibody IVD, kit, radioimmunoassay FDA UDI
Device Name
A radioimmunoassay for the semi-quantitative determination of antibodies to insulin in human serum. FDA UDI
Model / Reference
KR6790 FDA UDI
Description
A radioimmunoassay for the semi-quantitative determination of antibodies to insulin in human serum. FDA UDI

Identifiers

Catalog Number
KR6790 FDA UDI
Primary DI / UDI-DI
B126KR67900 FDA UDI
FDA Product Code
OCN FDA UDI
GMDN Term
Insulin antibody 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: Insulin antibody IVD, kit, radioimmunoassay

Kronus Insulin Autoantibody (iaa) Assay Kit by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin antibody IVD, kit, radioimmunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kronus, Inc.

Sources (1)

  • FDA UDI a980cf1a-4d23-478f-aaf1-8be9027b2a08 35 fields · synced Jun 8, 2026