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LifeSign® MI StatusFirst CK-MB/Myo/TnI card

FDA UDI

Class II (US FDA UDI)

by Princeton Biomeditech Corp.

Identity

Trade Name
LifeSign® MI StatusFirst CK-MB/Myo/TnI card FDA UDI
Generic Name
Troponin I IVD, kit, rapid ICT, clinical FDA UDI
Device Name
LifeSign® MI StatusFirst CK-MB/Myo/TnI; 1 Test kit; CE; Multilanguage FDA UDI
Model / Reference
LSC-300-01-00 FDA UDI
Description
LifeSign® MI StatusFirst CK-MB/Myo/TnI; 1 Test kit; CE; Multilanguage FDA UDI

Identifiers

Catalog Number
LSC-300-01-00 FDA UDI
Primary DI / UDI-DI
10743816001348 FDA UDI
510(k) Number
K981882 FDA UDI
FDA Product Code
MMI FDA UDI
JHT 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, clinicalCreatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K981882 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA UDI 8f7e9a92-a7db-4774-b419-b03c2582a526 37 fields · synced Jun 8, 2026