FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.™ TP TOTAL PROTEIN REAGENT CC217

Primary DI
00817302020755
Brand
CAROLINA LIQUID CHEMISTRIES CORP.™ TP TOTAL PROTEIN REAGENT CC217
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
CC217
Catalog number
CC217
Device description
TP (Total Protein) 2 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
CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications

CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020755008173020207558173020207550817302020755

GMDN Terms

TermDefinition
Total protein IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume101Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 20 days
Special Storage Condition, Specify00Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
Storage Environment Temperature8 Degrees Celsius30 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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