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QBC Diagnostics

FDA UDI

Class I (US FDA UDI)

by Drucker Diagnostics

Identity

Trade Name
QBC Diagnostics FDA UDI
Generic Name
Biological stain kit IVD FDA UDI
Device Name
QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (230V) FDA UDI
Model / Reference
427421 FDA UDI
Description
QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (230V) FDA UDI

Identifiers

Catalog Number
427421 FDA UDI
Primary DI / UDI-DI
00858092006222 FDA UDI
FDA Product Code
JSY FDA UDI
GKZ FDA UDI
GMDN Term
Biological stain kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Biological stain kit IVD

QBC Diagnostics by Drucker Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biological stain kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drucker Diagnostics

Sources (1)

  • FDA UDI 0c022170-28d0-44c2-b957-24286d1fd3a7 34 fields · synced May 30, 2026