FDA.reportPublic FDA data

Dimension® Dimension Vista® System Enzyme Diluent

Primary DI
00842768000102
Brand
Dimension® Dimension Vista® System Enzyme Diluent
Company
Siemens Healthcare Diagnostics Inc.
Model
10444870
Catalog number
790035901
Device description
Enzyme Diluent, 10x10mL
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
00842768000102PrimaryGS10
00630414003771Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768000102008427680001028427680001020842768000102
00630414003771006304140037716304140037710630414003771

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

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
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
10
DM exempt
false
Premarket exempt
false
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
true
No natural rubber latex
false
Sterilization required before use
false

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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
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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
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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
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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
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00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.CKA2020-09-24
00630414596365Atellica CH ALTSiemens Healthcare Diagnostics Inc.CKA2020-09-24