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QBC Diagnostics

FDA UDI

Class II (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, Microscope, and Centrifuge (115V) FDA UDI
Model / Reference
427400 FDA UDI
Description
QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives, Microscope, and Centrifuge (115V) FDA UDI

Identifiers

Catalog Number
427400 FDA UDI
Primary DI / UDI-DI
00858092006192 FDA UDI
FDA Product Code
GKZ FDA UDI
JSY FDA UDI
GMDN Term
Biological stain kit IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
866.2660 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

Yes

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 II — 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 ed7249bf-01f9-432c-bf59-66883deb736f 34 fields · synced May 30, 2026