FDA.reportPublic FDA data

Atellica CH ALTP5P

Primary DI
00630414596433
Brand
Atellica CH ALTP5P
Company
Siemens Healthcare Diagnostics Inc.
Model
11097598
Catalog number
11097598
Device description
Alanine Aminotransferase P5P (ALTP5P) Atellica CH - RGT 1684T
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00630414596433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596433006304145964336304145964330630414596433

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent Preparation Step
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00630414287201Atellica HEMA Calibrator11374312113743122026-02-06
00630414289694Atellica HEMA 580 Analyzer (SMS ready)11315457113154572026-02-06
00630414289700Atellica HEMA Slidemaker Stainer (SMS)11315459113154592026-02-06
00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

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