Identity
- Trade Name
- LifeSign® MI StatusFirst Troponin I card FDA UDI
- Generic Name
- Troponin I IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- LifeSign® MI StatusFirst Troponin I; 1 Test kit; CE; Multilanguage FDA UDI
- Model / Reference
- LSC-130-01-00 FDA UDI
- Description
- LifeSign® MI StatusFirst Troponin I; 1 Test kit; CE; Multilanguage FDA UDI
Identifiers
- Catalog Number
- LSC-130-01-00 FDA UDI
- Primary DI / UDI-DI
- 10743816001256 FDA UDI
- 510(k) Number
- K963513 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
LifeSign® MI StatusFirst Troponin I card by Princeton Biomeditech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Troponin I IVD, kit, rapid ICT, clinical.
- Roche CARDIAC TROP T Sensitive — Roche Diagnostics Corp. · Class II
- INSTANT-VIEW Troponin I Serum Cassette Test — Alfa Scientific Designs, Inc. · Class II
- RAMP® Troponin I TEST KIT; 25 TESTS — Response Biomedical Corp
- Nano-CheckTM AMI cTnI — Nano-Ditech Corporation · Class II
- INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette) — Alfa Scientific Designs, Inc. · Class II
- RapiCard™ InstaTest — Diagnostic Automation, Inc. · 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
Cleared under the same submission
K963513 also covers:
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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI e3d194bb-1212-4b2e-beaf-a31e59bbaf39 37 fields · synced Jun 8, 2026