FDA.report

COULTER TruColor Wright- Giemsa Stain Buffer

Primary DI
15099590250737
Brand
COULTER TruColor Wright- Giemsa Stain Buffer
Company
Beckman Coulter, Inc.
Model
7547181
Catalog number
7547181
Device description
COULTER TruColor Wright- Giemsa Stain Buffer
Published
2020-08-31
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
false

Related Records

Product Codes

CodeName
KQCStains, Hematology

Product Code Classifications

CodeDeviceSpecialtyClass
KQCStains, HematologyHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590250737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959025073715099590250737

GMDN Terms

TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
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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