← Back to catalogue

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, control FDA UDI
Device Name
Kallestad pANCA Positive Control, 0.5 mL FDA UDI
Model / Reference
29401 FDA UDI
Description
Kallestad pANCA Positive Control, 0.5 mL FDA UDI

Identifiers

Catalog Number
29401 FDA UDI
Primary DI / UDI-DI
00847817016097 FDA UDI
510(k) Number
K982898 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control 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

Dimensions & Sizes

Size
Total Volume — 0.5 Milliliter FDA UDI

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

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, control.

Cleared under the same submission

K982898 also covers:

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
Bio-Rad Laboratories

Sources (1)

  • FDA UDI cb3e0335-b944-4a54-b727-bfbca4d6dafb 38 fields · synced Jun 8, 2026