Autoimmune EIA 576AN

GUDID 00847817021688

Autoimmune EIA ANA Screening Test

BIO-RAD LABORATORIES, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00847817021688
NIH Device Record Keybc4c5d3c-2e53-4123-a844-d3a0c0821b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoimmune EIA
Version Model Number576AN
Catalog Number576AN
Company DUNS884513334
Company NameBIO-RAD LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847817021688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKJANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2016-09-12

On-Brand Devices [Autoimmune EIA]

00847817022463Autoimmune EIA Anti-ssDNA Test
00847817022456Autoimmune EIA Anti-Sm/RNP Test
00847817022449Autoimmune EIA Anti-Sm Test
00847817022432Autoimmune EIA Anti-Scl-70 Test
00847817022425Autoimmune EIA Anti-SS-B/La Test
00847817022418Autoimmune EIA Anti-SS-A/Ro Test
00847817022401Autoimmune EIA Anti-Jo-1 Test
00847817022388Autoimmune EIA ENA Plus Screening test
00847817022364Autoimmune EIA Anti-dsDNA Test
00847817022340Autoimmune EIA Anti-Centromere Test
00847817022319Autoimmune EIA ANA Screening Test
00847817021688Autoimmune EIA ANA Screening Test
00847817018695Autoimmune EIA anti - Proteinase 3 (PR3) Test
00847817018657Autoimmune EIA anti - Myeloperoxidase (MPO) Test
00847817018541Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgG
00847817018534Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgA
00847817018343Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgG
00847817018336Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA
00847817018329Autoimmune EIA Anti-Gliadin IgG
00847817018312Autoimmune EIA Anti-Gliadin IgA
00847817018282Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit
00847817018275Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit
00847817018268Autoimmune EIA Anti-Phosphatidylserine IgG Test
00847817018251Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit
00847817018244Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit
00847817018237Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit
00847817018220Autoimmune EIA Anti-Cardiolipin IgA Test Kit
00847817018213Autoimmune EIA Anti-Cardiolipin IgM Test Kit
00847817018206Autoimmune EIA Anti-Cardiolipin IgG Test Kit
00847817007040Autoimmune EIA DNA Wash Concentrate, 60 mL
00847817007033Autoimmune EIA DNA Sample Diluent, 30 mL
00847817007026Autoimmune EIA Wash Concentrate, 60 mL
00847817007019Autoimmune EIA Sample Diluent, 30 mL
00847817006999Autoimmune EIA Substrate, 15 mL
00847817006982Autoimmune EIA Stop Solution, 15 mL
00847817006944Autoimmune EIA ENA Conjugate, 15 mL
00847817006937Autoimmune EIA DNA Conjugate, 15 mL
00847817006913Autoimmune EIA Stop Solution, 15 mL
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