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.

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• 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

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• 00850049545518 - AccuDiag™: 2024-05-20 AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA
• 00850054026590 - QMedix™: 2024-05-20 QMedix™ Fecal Occult Blood RapiCard™ InstaTest
• 00850054026569 - QMedix™: 2024-05-01 QMedix™ ANA Screen ELISA
• 00850054026262 - AccuDiag ™: 2024-04-04 AccuDiag™ TSH Ultra-Sensitive ELISA