FDA.report

ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)

Primary DI
10673486001082
Brand
ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)
Company
TECO DIAGNOSTICS
Model
A524-150
Catalog number
A524-150
Device description
The ALT(SGPT) Liquid Reagent (Kinetic Method) is used for the quantitative determination of alanine aminotransferase in serum used in routine examination and monitoring of therapy and relapses.
Published
2023-07-17
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

Contact Domains

Product Codes

CodeName
CKANadh Oxidation/Nad Reduction, Alt/Sgpt

Product Code Classifications

CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10673486001082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1067348600108210673486001082

GMDN Terms

TermDefinition
Alanine aminotransferase (ALT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
714-463-1111hello@tecodiagnostics.com

Regulatory Flags

DUNS number
185067774
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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