FDA.report

AU

Primary DI
15099590010171
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6119
Device description
Gamma-Glutamyltransferase (GGT)
Published
2016-09-24
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
JQBKinetic Method, Gamma-Glutamyl Transpeptidase

Product Code Classifications

CodeDeviceSpecialtyClass
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590010171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959001017115099590010171

GMDN Terms

TermDefinition
Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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