FDA.report

POINTE SCIENTIFIC ALT (SGPT) Liquid

Primary DI
00811727010223
Brand
POINTE SCIENTIFIC ALT (SGPT) Liquid
Company
POINTE SCIENTIFIC, INC.
Model
A7526-450
Catalog number
A7526-450
Device description
For the quantitative determination of Alanine Aminotransferase in serum.
Published
2016-08-31
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
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
00811727010223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010223008117270102238117270102230811727010223

GMDN Terms

TermDefinition
Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) 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
800-445-9853techservice@medtest.com

Regulatory Flags

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28
00811727018632Pointe Scientific CK-MBC7563-30C7563-302021-02-28
00811727018649Pointe Scientific CK-MBC7563-90C7563-902021-02-28
00811727014139Pointe G6PD ReagentG7583-180G7583-1802021-01-30
00811727015594Pointe Lipoprotein (a) Control SetL7597-CTLL7597-CTL2021-01-30
00811727015679Pointe G6PD ControlsG7583-CTLG7583-CTL2021-01-30
00811727015815Pointe CRP Reagent14-C7568-48014-C7568-4802021-01-30
00811727015891Pointe Lactate Reagent 14-L7596-38014-L7596-3802021-01-30
00811727015907Pointe Lactate Dehydrogenase Reagent14-L7572-20014-L7572-2002021-01-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
10673486001082ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
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
00817302024296CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT CC240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19
00817302024456CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT DT240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19
00817302024593CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT ST240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19
00380740155704AlinityABBOTT IRELANDCKA2022-06-14
00380740155711AlinityABBOTT IRELANDCKA2022-06-14
00380740155728ARCHITECTABBOTT IRELANDCKA2022-06-14
00380740155742ARCHITECTABBOTT IRELANDCKA2022-06-14
00380740170035ARCHITECTABBOTT IRELANDCKA2022-05-24
00380740170042ARCHITECTABBOTT IRELANDCKA2022-05-24
00380740170059AlinityABBOTT IRELANDCKA2022-02-28
00811727016027Pointe ALT Reagent POINTE SCIENTIFIC, INC.CKA2021-01-30
04015630913862Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activationRoche Diagnostics GmbHCKA2021-01-18
04015630920532Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activationRoche Diagnostics GmbHCKA2021-01-18
04015630921973Alanine aminotransferase acc. IFCC with or without PYPRoche Diagnostics GmbHCKA2021-01-18
04015630927425Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYPRoche Diagnostics GmbHCKA2021-01-18
04015630928927Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activationRoche Diagnostics GmbHCKA2021-01-18
00630414009056Atellica CH ALTPLcSiemens Healthcare Diagnostics Inc.CKA2020-09-24
00630414508368ADVIA® Chemistry ALT(GPT) ReagentsSiemens Healthcare Diagnostics Inc.CKA2020-09-24
00630414517483ADVIA® Chemistry Alanine Aminotransferase ALT ReagentsSiemens Healthcare Diagnostics Inc.CKA2020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.CKA2020-09-24
00630414596365Atellica CH ALTSiemens Healthcare Diagnostics Inc.CKA2020-09-24