CAROLINA LIQUID CHEMISTRIES CORP.® MALB RGT. KIT AU-662 AU-662

GUDID 00817302020960

MALB (Microalbumin) 2 x 100 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Microalbumin IVD, kit, enzyme spectrophotometry
Primary Device ID00817302020960
NIH Device Record Keyc1263297-6a3c-4943-ba05-35389d4e7a0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® MALB RGT. KIT AU-662
Version Model NumberAU-662
Catalog NumberAU-662
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 Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020960 [Primary]

FDA Product Code

DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL

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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