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Spotcheck

FDA UDI

Class II (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Biotinidase IVD, kit, spectrophotometry FDA UDI
Device Name
Biotinidase 50 Hour Reagent Kit FDA UDI
Model / Reference
80-8000-CA FDA UDI
Description
Biotinidase 50 Hour Reagent Kit FDA UDI

Identifiers

Catalog Number
80-8000-CA FDA UDI
Primary DI / UDI-DI
00725609000083 FDA UDI
510(k) Number
K010844 FDA UDI
FDA Product Code
NAK FDA UDI
GMDN Term
Biotinidase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1118 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

Yes

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: Biotinidase IVD, kit, spectrophotometry

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

Similar devices

Also classified as Biotinidase IVD, kit, spectrophotometry.

Cleared under the same submission

K010844 also covers:

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 d18ec334-bcda-4577-ac65-f1c88460007f 35 fields · synced May 30, 2026