FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT AU-241

Primary DI
00817302020335
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT AU-241
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
AU-241
Catalog number
AU-241
Device description
AST (Aspartate Aminotransferase) 3 x 250 tests
Published
2016-09-01
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

Related Records

Contact Domains

Product Codes

CodeName
CITNadh oxidation/nad reduction, ast/sgot

Product Code Classifications

CodeDeviceSpecialtyClass
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020335008173020203358173020203350817302020335

GMDN Terms

TermDefinition
Aspartate aminotransferase (AST) isoenzyme 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 qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume8Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)471-7272ContactSales@CarolinaChemistries.com

Regulatory Flags

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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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00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
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00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

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