FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207

Primary DI
00817302020489
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
ST207
Catalog number
ST207
Device description
CK (Creatine Kinase) 4 x 300 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
CGSNAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Product Code Classifications

CodeDeviceSpecialtyClass
CGSNad Reduction/Nadh Oxidation, Cpk Or IsoenzymesClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020489008173020204898173020204890817302020489

GMDN Terms

TermDefinition
Creatine kinase (CK) multiple 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 creatine kinase (CK) isoenzymes in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume17Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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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