CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 CC691

GUDID 00817302020069

CYST (Cystatin-C) 2 x 100 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Cystatin C IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00817302020069
NIH Device Record Key4ad9451a-b8c3-4536-832f-ec436ece12ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691
Version Model NumberCC691
Catalog NumberCC691
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
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com

Device Dimensions

Device Size Text, specify0
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Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0
Total Volume4.5 Milliliter
Total Volume20 Milliliter
Device Size Text, specify0

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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents are stable to expiration date with 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020069 [Primary]

FDA Product Code

NDYTEST, CYSTATIN C

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

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