CitoCBC Control

Primary DI
00850063751315
Brand
CitoCBC Control
Company
CYTOCHIP INC
Model
1310
Device description
CitoCBC Control is a tri-level control material designed to monitor the performance of the CitoCBC Analyzer.
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063751315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063751315008500637513158500637513150850063751315

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081107751
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063751117CitoCBC Analyzer11102025-07-01
00850063751216CitoCBC Cartridge12102025-07-01