RapiCard™ InstaTest 166772-1-19

GUDID 00894175000466

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

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

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

MMI	Immunoassay Method, Troponin Subunit

Steralize Prior To Use	false
Device Is Sterile	false

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Mark Image Registration \| Serial	Company Trademark Application Date
RAPICARD 76200987 2660489 Live/Registered	DIAGNOSTIC AUTOMATION, INC. 2001-01-29
RAPICARD 74644626 not registered Dead/Abandoned	LATELCO, INC. 1995-03-10