FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)

Primary DI
00852169008034
Brand
ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)
Company
CLEARCHEM DIAGNOSTICS INC.
Model
ALT1020
Catalog number
ALT1020
Device description
In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
Published
2018-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00852169008034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008034008521690080348521690080340852169008034

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume225Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Refrigerated
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)734-8041dwheat@clearchem.net

Regulatory Flags#

DUNS number
010655581
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00852169008171ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)CRP1320CRP13202018-04-30
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolLDL1230LDL12302018-05-18
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalMPN2020MPN20202018-06-08
00852169008232ClearChem Diagnostics Inc. TIBC-DirectITI1160ITI11602018-05-22
00852169008270ClearChem Diagnostics Inc. MicroAlbuminMAL1010MAL10102018-05-22
00852169008287ClearChem Diagnostics Inc. Hemoglobin A-1cHGB1200HGB12002018-05-22
00852169008058ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)AST1040AST10402018-05-18
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolHDL1210HDL12102018-05-18
00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CAR1090CAR10902018-04-30
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)ALP1010ALP10102018-04-30
00852169008041ClearChem Diagnostics Inc. AmylaseAMY1030AMY10302018-04-30
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)BUN1070BUN10702018-04-30
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CPK1110CPK11102018-04-30
00852169008096ClearChem Diagnostics Inc. Bilirubin, DirectBRD1050BRD10502018-04-30

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Primary DI, Brand, Company table
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10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
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