FDA.report

GAMMA-GLUTAMYLTRANSERASE (GGT)

Primary DI
05055273208801
Brand
GAMMA-GLUTAMYLTRANSERASE (GGT)
Company
RANDOX LABORATORIES LIMITED
Model
GT8320
Catalog number
GT8320
Device description
A Gamma GT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum.
Published
2022-09-22
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

Contact Domains

Product Codes

CodeName
JPZColorimetric Method, Gamma-Glutamyl Transpeptidase

Product Code Classifications

CodeDeviceSpecialtyClass
JPZColorimetric Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273208801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273208801050552732088015055273208801

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags

DUNS number
227530649
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
false
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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