FDA.report

ALT (SGPT) KINETIC METHOD TC MATRIX-240/480

Primary DI
10673486001099
Brand
ALT (SGPT) KINETIC METHOD TC MATRIX-240/480
Company
TECO DIAGNOSTICS
Model
A524-780
Catalog number
A524-780
Device description
The ALT (SGPT) KINETIC METHOD TC MATRIX-240/480 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
10673486001099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1067348600109910673486001099

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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001112ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-10-18
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19
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00380740155704AlinityABBOTT IRELANDCKA2022-06-14
00380740155711AlinityABBOTT IRELANDCKA2022-06-14
00380740155728ARCHITECTABBOTT IRELANDCKA2022-06-14
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00380740170042ARCHITECTABBOTT IRELANDCKA2022-05-24
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00811727016027Pointe ALT Reagent POINTE SCIENTIFIC, INC.CKA2021-01-30
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04015630921973Alanine aminotransferase acc. IFCC with or without PYPRoche Diagnostics GmbHCKA2021-01-18
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