AccuDiag™ 1202-2

GUDID 00894175000558

AccuDiag™ Cytomegalovirus IgM ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000558
• NIH Device Record Key: 22334768-596d-414e-a9c7-4eeb4e25dbf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag™
• Version Model Number: DACD 1202-2
• Catalog Number: 1202-2
• 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
• 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
• 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
• 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	00894175000558 [Primary]

FDA Product Code

• LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

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: 2021-12-07
• Device Publish Date: 2021-11-29

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