INSTANT-VIEW Troponin I Serum Cassette Test

FDA UDI

Class II (US FDA UDI)

by Alfa Scientific Designs, Inc.

Identity

Trade Name: INSTANT-VIEW Troponin I Serum Cassette Test FDA UDI
Generic Name: Troponin I IVD, kit, rapid ICT, clinical FDA UDI
Device Name: INSTANT-VIEW Troponin I Serum Cassette Test FDA UDI
Model / Reference: 05-8572 FDA UDI
Description: INSTANT-VIEW Troponin I Serum Cassette Test FDA UDI

Identifiers

Primary DI / UDI-DI: 10796918001792 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

INSTANT-VIEW Troponin I Serum Cassette Test by Alfa Scientific Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Alfa Scientific Designs, Inc.

Sources (1)

FDA UDI 0402d6c7-b5f2-4227-b944-25ccaf1069e9 33 fields · synced Jun 9, 2026