AccuDiag ™ 1301-2

GUDID 00894175000039

AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.

Diagnostic Automation, Inc.

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000039
• NIH Device Record Key: d9d8bf1e-708c-4b97-ae2c-d298c859fe07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag ™
• Version Model Number: DACD 1301-2
• Catalog Number: 1301-2
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, 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: false
• 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: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.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
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *between 2 and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000039 [Primary]

FDA Product Code

• OPL: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-18
• Device Publish Date: 2021-08-10

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