RapiCard™ InstaTest 166772-1-19

GUDID 00894175000466

OneStep Troponin I RapiCard™ InstaTest (Serum/WB) A collection of reagents and other associated materials intended to be used for the qualitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Diagnostic Automation, Inc.

Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, immunochromatographic test (ICT), rapid Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical

• Primary Device ID: 00894175000466
• NIH Device Record Key: 1e4070b8-d92a-4dc5-a9d9-9a877ca0d7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapiCard™ InstaTest
• Version Model Number: DACD166772-1-19
• Catalog Number: 166772-1-19
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, Inc.
• Device Count: 25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000442 [Unit of Use]
GS1	00894175000466 [Primary]

FDA Product Code

• MMI: Immunoassay Method, Troponin Subunit

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: 2021-09-06
• Device Publish Date: 2021-08-27

Devices Manufactured by Diagnostic Automation, Inc.

• 00850054026569 - QMedix™: 2024-05-01 QMedix™ ANA Screen ELISA
• 00850054026262 - AccuDiag ™: 2024-04-04 AccuDiag™ TSH Ultra-Sensitive ELISA
• 00894175000138 - AccuDiag ™: 2024-04-04 AccuDiag™ Echinococcus IgG ELISA
• 00850049545211 - AccuDiag ™: 2024-03-14 AccuDiag™ Leptospira IgM ELISA -
• 00850049545259 - AccuDiag ™: 2024-03-14 AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM ELISA A collection of reagents and other associated materials intended to be used for t
• 00850054026538 - QMedix™: 2024-03-14 QMedix™ TSH Ultra Sensitive ELISA A collection of reagents and other associated materials intended to be used for the quantita
• 00894175000114 - AccuDiag ™: 2024-03-14 AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of th
• 00894175000282 - AccuDiag ™: 2024-03-14 AccuDiag™ Fasciola IgG ELISA