ST AIA-PACK cTnI 2

FDA UDI

Class II (US FDA UDI)

by Tosoh Corp.

Identity

Trade Name: ST AIA-PACK cTnI 2 FDA UDI
Generic Name: Troponin I IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference: N/A FDA UDI

Identifiers

Primary DI / UDI-DI: 14560189210117 FDA UDI
FDA Product Code: MMI FDA UDI
GMDN Term: Troponin I IVD, kit, enzyme immunoassay (EIA) 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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, enzyme immunoassay (EIA)

ST AIA-PACK cTnI 2 by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Troponin I IVD, kit, enzyme immunoassay (EIA).

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Dimension Cardiac Troponin-I Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
cTnI AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
i-STAT hs-TnI cartridge — Abbott Point of Care Inc. · Class II
Dimension Cardiac Troponin-I Flex reagent cartridge — Siemens Healthcare Diagnostics · 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

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Manufacturer

Manufacturer: Tosoh Corp.

Sources (1)

FDA UDI 8b7c714d-ac0f-44d3-8174-72673de7eb92 34 fields · synced May 30, 2026