AccuDiag ™ 2553-1

GUDID 00894175000237

AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Diagnostic Automation, Inc.

Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000237
• NIH Device Record Key: bd5f335b-9cd6-416c-86bc-5d6ebb5c3204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag ™
• Version Model Number: DACD-2553-1
• Catalog Number: 2553-1
• 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: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com
• Phone: 8185913030
• Email: marketing@rapidtest.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000237 [Primary]

FDA Product Code

• LSW: Anti-Dna Antibody, Antigen And Control

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: 2021-08-16
• Device Publish Date: 2021-08-06

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