Liquid Select Amylase Reagent

FDA UDI

Class II (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name: Liquid Select Amylase Reagent FDA UDI
Generic Name: Total amylase IVD, kit, spectrophotometry FDA UDI
Model / Reference: 80-5451-00 FDA UDI

Identifiers

Catalog Number: 80-5451-00 FDA UDI
Primary DI / UDI-DI: 00628063400133 FDA UDI
FDA Product Code: JFJ FDA UDI
GMDN Term: Total amylase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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: Total amylase IVD, kit, spectrophotometry

Liquid Select Amylase Reagent by Sekisui Diagnostics, LLC — 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: Sekisui Diagnostics, LLC

Sources (1)

FDA UDI faea32a4-077a-457f-9dd2-0eea7f1f7feb 33 fields · synced Jun 9, 2026