Autoimmune EIA 96AN

GUDID 00847817022319

Autoimmune EIA ANA Screening Test

BIO-RAD LABORATORIES, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00847817022319
• NIH Device Record Key: 21dee922-585f-43e1-a369-bff11ae5191f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoimmune EIA
• Version Model Number: 96AN
• Catalog Number: 96AN
• Company DUNS: 884513334
• Company Name: BIO-RAD LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817022319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954723

FDA Product Code

• LKJ: ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Autoimmune EIA]

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