FDA.reportPublic FDA data

Pointe Scientfic Inc.

Primary DI
00811727012548
Brand
Pointe Scientfic Inc.
Company
POINTE SCIENTIFIC, INC.
Model
HA926-610
Catalog number
HA926-610
Device description
ALT Reagent Set for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 5 x 100ml, 2 x 55ml
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CKANadh Oxidation/Nad Reduction, Alt/Sgpt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727012548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727012548008117270125488117270125480811727012548

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
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