FDA.report

ARCHITECT

Primary DI
00380740161651
Brand
ARCHITECT
Company
Abbott GmbH & Co. KG
Model
7D56-22
Catalog number
07D5622
Device description
Alanine Aminotransferase
Published
2019-11-15
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
00380740161651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740161651003807401616513807401616510380740161651

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
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
315786293
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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00380740174965ARCHITECT6L45-2206L45222020-04-12
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00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27

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