Identity
- Trade Name
- RapiCard™ InstaTest FDA UDI
- Generic Name
- Troponin I IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DACD166772-1-19 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 166772-1-19 FDA UDI
- Primary DI / UDI-DI
- 00894175000466 FDA UDI
- FDA Product Code
- MMI FDA UDI
- GMDN Term
- Troponin I IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Troponin I IVD, kit, rapid ICT, clinical
RapiCard™ InstaTest by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Troponin I IVD, kit, rapid ICT, clinical.
- LifeSign® MI StatusFirst Troponin I card — PRINCETON BIOMEDITECH CORP. · Class II
- LifeSign® MI StatusFirst CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- LifeSign® MI Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- Roche CARDIAC TROP T Sensitive — Roche Diagnostics Corp. · Class II
- INSTANT-VIEW Troponin I Serum Cassette Test — Alfa Scientific Designs, Inc. · Class II
- LifeSign® MI StatusFirst CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- RAMP® Troponin I TEST KIT; 25 TESTS — Response Biomedical Corp
- LifeSign® MI CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 1e4070b8-d92a-4dc5-a9d9-9a877ca0d7d6 36 fields · synced Jun 8, 2026