AccuDiag ™ 8209-35

GUDID 00894175000114

AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000114
• NIH Device Record Key: 38955e07-67a7-4240-ab68-f4a7ef365991
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag ™
• Version Model Number: DACD8209-35
• Catalog Number: 8209-35
• 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
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000114 [Primary]

FDA Product Code

• GNH: Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

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: 2024-03-14
• Device Publish Date: 2024-03-06

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