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Kallestad ANCA

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Kallestad ANCA FDA UDI
Generic Name
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent FDA UDI
Device Name
Kallestad ANCA Coverslips, 12 FDA UDI
Model / Reference
29413 FDA UDI
Description
Kallestad ANCA Coverslips, 12 FDA UDI

Identifiers

Catalog Number
29413 FDA UDI
Primary DI / UDI-DI
00847817016172 FDA UDI
510(k) Number
K982898 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent 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

No

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: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent

Kallestad ANCA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent.

Cleared under the same submission

K982898 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI b901307f-2079-449b-919e-07df4c232442 38 fields · synced May 31, 2026