CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 AU-632

GUDID 00817302020885

APO A1 (Apolipoprotein A1) 3 x 200 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Primary Device ID00817302020885
NIH Device Record Key15c239d8-5dd9-40ee-8df2-e631fa097c5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632
Version Model NumberAU-632
Catalog NumberAU-632
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

Device Dimensions

Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter
Device Size Text, specify0
Total Volume46 Milliliter
Total Volume16 Milliliter

Operating and Storage Conditions

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 when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
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
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020885 [Primary]

FDA Product Code

DERALPHA-1-LIPOPROTEIN, 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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