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CitoCBC Cartridge

FDA UDI

Class II (US FDA UDI)

by Cytochip, Inc.

Identity

Trade Name
CitoCBC Cartridge FDA UDI
Generic Name
Full blood count IVD, kit, cell count FDA UDI
Device Name
The CitoCBC Cartridge is intended for use on the CitoCBC Analyzer to perform complete blood count (CBC) test. FDA UDI
Model / Reference
1210 FDA UDI
Description
The CitoCBC Cartridge is intended for use on the CitoCBC Analyzer to perform complete blood count (CBC) test. FDA UDI

Identifiers

Primary DI / UDI-DI
00850063751216 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: Full blood count IVD, kit, cell count

CitoCBC Cartridge by Cytochip, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cytochip, Inc.

Sources (1)

  • FDA UDI 78d8c886-4fc3-459c-9ee1-b7ba5a7a545b 33 fields · synced May 30, 2026