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Modified Kronus Test Kit For Antibodies To (tpo)

FDA UDI

Class II (US FDA UDI)

by Kronus, Inc.

Identity

Trade Name
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) FDA UDI
Generic Name
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay FDA UDI
Device Name
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum. FDA UDI
Model / Reference
KR6215 FDA UDI
Description
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum. FDA UDI

Identifiers

Catalog Number
KR6215 FDA UDI
Primary DI / UDI-DI
B126KR62150 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 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: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay

Modified Kronus Test Kit For Antibodies To (tpo) by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kronus, Inc.

Sources (1)

  • FDA UDI 4885f0ea-4f6c-471c-b8b3-77110ddd0b2b 35 fields · synced May 30, 2026