QBC Diagnostics

FDA UDI

Class II (US FDA UDI)

by Drucker Diagnostics

Identity

Trade Name: QBC Diagnostics FDA UDI
Generic Name: Full blood count IVD, kit, cell count FDA UDI
Device Name: Refurbished QBC STAR-I Centrifugal Hematology System, Biochem: Refurbished QBC STAR-I Analyzer - Biochem; QBC Disposable Starter Kit (20 STAR Tubes) FDA UDI
Model / Reference: 42900209C FDA UDI
Description: Refurbished QBC STAR-I Centrifugal Hematology System, Biochem: Refurbished QBC STAR-I Analyzer - Biochem; QBC Disposable Starter Kit (20 STAR Tubes) FDA UDI

Identifiers

Catalog Number: 42900209C FDA UDI
Primary DI / UDI-DI: 00858092006567 FDA UDI
510(k) Number: K992849 FDA UDI
FDA Product Code: GKZ FDA UDI
GMDN Term: Full blood count IVD, kit, cell count FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Full blood count IVD, kit, cell count

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

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Cleared under the same submission

K992849 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Drucker Diagnostics

Sources (1)

FDA UDI fb883136-d2ce-43fc-8728-f4572167fd33 35 fields · synced May 30, 2026