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 Autoread Plus Instrument, Human, Domestic FDA UDI
Model / Reference: 42857609 FDA UDI
Description: Refurbished QBC Autoread Plus Instrument, Human, Domestic FDA UDI

Identifiers

Catalog Number: 42857609 FDA UDI
Primary DI / UDI-DI: 00858092006079 FDA UDI
510(k) Number: K960827 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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

Similar devices

Also classified as Full blood count IVD, kit, cell count.

M-30R — Shenzhen Mindray Bio-Medical Electronics Co. · Class I
Drew Scientific — Drew Scientific , Ltd. · Class I
M-30D Diluent — Shenzhen Mindray Bio-Medical Electronics Co. · Class I
ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC — Siemens Healthcare Diagnostics · Class II
CitoCBC Cartridge — Cytochip, Inc. · Class II
QBC Diagnostics — DRUCKER DIAGNOSTICS · Class II
QBC Diagnostics — DRUCKER DIAGNOSTICS · Class II
QBC Diagnostics — DRUCKER DIAGNOSTICS · Class II

Cleared under the same submission

K960827 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Drucker Diagnostics

Sources (1)

FDA UDI d7066132-2ca6-460d-80a1-5e1d5473e893 35 fields · synced Jun 1, 2026