CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 CC638

GUDID 00817302020953

IgM (Immunoglobulin M) 2 x 60 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00817302020953
NIH Device Record Key1db003e5-1227-4559-9961-8c6118dea626
Commercial Distribution Discontinuation2018-08-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638
Version Model NumberCC638
Catalog NumberCC638
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

Device Dimensions

Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 Milliliter
Total Volume23 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020953 [Primary]

FDA Product Code

CFFIMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-28
Device Publish Date2016-09-01

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