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Spotcheck

FDA UDI

Class I (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Multiple amino acid/carnitine metabolite IVD, control FDA UDI
Device Name
MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carnitine, Acylcarnitine, and Succinylacetone) for Quality Control Use with Tandem Mass Spectrometry (MS/MS) Newborn Screening Systems FDA UDI
Model / Reference
82-0200P6K FDA UDI
Description
MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carnitine, Acylcarnitine, and Succinylacetone) for Quality Control Use with Tandem Mass Spectrometry (MS/MS) Newborn Screening Systems FDA UDI

Identifiers

Catalog Number
82-0200P6K FDA UDI
Primary DI / UDI-DI
00725609000526 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple amino acid/carnitine metabolite IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple amino acid/carnitine metabolite IVD, control

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

Similar devices

Also classified as Multiple amino acid/carnitine metabolite IVD, control.

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 7ec89153-e5a3-4a73-b97f-b2ea9e09d97c 34 fields · synced May 30, 2026