Identity
- Trade Name
- Nano-CheckTM AMI cTnI FDA UDI
- Generic Name
- Troponin I IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma FDA UDI
- Model / Reference
- CD7141 FDA UDI
- Description
- In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma FDA UDI
Identifiers
- Catalog Number
- CD7141 FDA UDI
- Primary DI / UDI-DI
- 00895160002076 FDA UDI
- 510(k) Number
- K102131 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
Yes
FDA UDI
Category: Troponin I IVD, kit, rapid ICT, clinical
Nano-CheckTM AMI cTnI by Nano-Ditech Corporation — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 1a9f3bc0-9ed4-4a0e-931d-7e2253521b57 37 fields · synced Jun 9, 2026