StatusFirst™ Tn I card

FDA UDI

Class II (US FDA UDI)

by Princeton Biomeditech Corp.

Identity

Trade Name: StatusFirst™ Tn I card FDA UDI
Generic Name: Troponin I IVD, kit, rapid ICT, clinical FDA UDI
Device Name: StatusFirst™ Tn I; Quantitative; 20 Test kit; CE FDA UDI
Model / Reference: LSC-131-20-00 FDA UDI
Description: StatusFirst™ Tn I; Quantitative; 20 Test kit; CE FDA UDI

Identifiers

Catalog Number: LSC-131-20-00 FDA UDI
Primary DI / UDI-DI: 10743816001263 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Troponin I IVD, kit, rapid ICT, clinical

StatusFirst™ Tn 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.

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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 Troponin I card — PRINCETON BIOMEDITECH CORP. · Class II
LifeSign® MI StatusFirst CK-MB/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

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Manufacturer

Manufacturer: Princeton Biomeditech Corp.

Sources (1)

FDA UDI a6cc9a30-13f2-4956-a65f-eac4ce797a50 37 fields · synced May 29, 2026