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Spotcheck

FDA UDI

Class II (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Phenylalanine IVD, kit, enzyme fluorescence FDA UDI
Device Name
Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates FDA UDI
Model / Reference
81-1100-05K FDA UDI
Description
Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates FDA UDI

Identifiers

Catalog Number
81-1100-05K FDA UDI
Primary DI / UDI-DI
00725609000601 FDA UDI
510(k) Number
K974047 FDA UDI
FDA Product Code
JNB FDA UDI
GMDN Term
Phenylalanine IVD, kit, enzyme fluorescence FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1555 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Phenylalanine IVD, kit, enzyme fluorescence

Spotcheck by Astoria-Pacific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phenylalanine IVD, kit, enzyme fluorescence.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Astoria-Pacific, Inc.

Sources (1)

  • FDA UDI e48c26d2-2f0b-4c05-a962-7e4821f56d88 35 fields · synced May 30, 2026