← Back to catalogue

LifeSign® MI Myo/TnI card

FDA UDI

Class II (US FDA UDI)

by Princeton Biomeditech Corp.

Identity

Trade Name
LifeSign® MI Myo/TnI card FDA UDI
Generic Name
Troponin I IVD, kit, rapid ICT, clinical FDA UDI
Device Name
LifeSign® MI Myo/TnI; 20 Test kit FDA UDI
Model / Reference
LSC-210-20-00 FDA UDI
Description
LifeSign® MI Myo/TnI; 20 Test kit FDA UDI

Identifiers

Catalog Number
LSC-210-20-00 FDA UDI
Primary DI / UDI-DI
10743816001294 FDA UDI
510(k) Number
K022946 FDA UDI
FDA Product Code
MMI FDA UDI
DEA 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
866.5680 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, clinicalMyoglobin IVD, kit, rapid ICT, clinical

LifeSign® MI Myo/TnI card by Princeton Biomeditech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Myoglobin IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA UDI 04203474-0be8-4ea8-a55b-9d953f0ba4af 37 fields · synced May 31, 2026