AccuDiag ™ 1444-2

GUDID 00894175000046

AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.

Diagnostic Automation, Inc.

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000046
• NIH Device Record Key: 9b32b834-fdb9-435f-8cee-9a5f2b0202e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag ™
• Version Model Number: DACD 1444-2
• Catalog Number: 1444-2
• 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	00894175000046 [Primary]

FDA Product Code

• LGC: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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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