FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052

Primary DI
00817302020106
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
CC052
Catalog number
CC052
Device description
HCY (Homocysteine) Level 2 control 6 x 5 mL
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
JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020106008173020201068173020201060817302020106

GMDN Terms

TermDefinition
Homocysteine IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Controls are stable if refrigerated (2 to 8 °) until the date of expiration
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
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

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