FDA.report

Beckman coulter

Primary DI
15099590225940
Brand
Beckman coulter
Company
IMMUNOTECH
Model
B31167
Catalog number
B31167
Device description
PerFix-nc (no centrifuge assay Kit)
Published
2020-01-21
Public version status
New
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
GGKProducts, Red-Cell Lysing Products

Product Code Classifications

CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590225940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959022594015099590225940

GMDN Terms

TermDefinition
White blood cell count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
270264732
Device count
1
DM exempt
false
Premarket exempt
true
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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