FDA.report

CYTO-COMP REAGENT

Primary DI
15099590540388
Brand
CYTO-COMP REAGENT
Company
Beckman Coulter, Inc.
Model
6607021
Catalog number
6607021
Device description
CYTO-COMP Reagent Kit
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GKZCounter, Differential Cell

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590540388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959054038815099590540388

GMDN Terms

TermDefinition
Multiple CD cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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