CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 BL343

GUDID 00817302020052

CREAu (Creatinine, Urine) only

CAROLINA LIQUID CHEMISTRIES CORPORATION

Creatine IVD, kit, enzyme spectrophotometry
Primary Device ID00817302020052
NIH Device Record Keyeb2bb8c1-5433-46c7-814a-709ed3027034
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343
Version Model NumberBL343
Catalog NumberBL343
Company DUNS962385787
Company NameCAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com

Device Dimensions

Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Total Volume25 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020052 [Primary]

FDA Product Code

JFYENZYMATIC METHOD, CREATININE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-04
Device Publish Date2016-09-01

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