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| 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 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| 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.
| 00850049545433 - AccuDiag™ Prolactin (PRL) ELISA | 2026-02-09 AccuDiag™ Prolactin (PRL) ELISA A collection of reagents and other associated materials intended to be used for the qualitativ |
| 00850054026712 - AccuDiag™ LH ELISA | 2026-02-09 AccuDiag™ (Luteinizing hormone ) LH ELISA |
| 00894175000800 - AccuDiag™ Progesterone ELISA | 2026-02-09 AccuDiag™ Progesterone ELISA A collection of reagents and other associated materials intended to be used for the qualitative a |
| 00850049545723 - AccuDiag™ Insulin ELISA | 2026-02-04 AccuDiag™ Insulin ELISA A collection of reagents and other associated materials intended to be used for the quantitative measu |
| 00850049545815 - AccuDiag™ Human Growth Hormone (HGH) ELISA | 2026-02-04 AccuDiag™ Human Growth Hormone (HGH) ELISA A collection of reagents and other associated materials intended to be used for the |
| 00850054026255 - AccuDiag™ C-Peptide ELISA Kit | 2026-02-04 AccuDiag™ C-Peptide ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative |
| 00850054026682 - AccuDiag™ Estradiol ELISA | 2026-02-04 AccuDiag™ Estradiol ELISA Kit A collection of reagents and other associated materials intended to be used for the quantitative |
| 00850054026705 - AccuDiag™ FSH ELISA | 2026-02-04 AccuDiag™ FSH ELISA |
Trademark Results [RapiCard]
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 |
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