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Spotcheck

FDA UDI

Class II (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Galactose-1-phosphate uridyl transferase IVD, calibrator FDA UDI
Device Name
NADH Stock Standard, 10 x 50 mL FDA UDI
Model / Reference
80-4060P10K FDA UDI
Description
NADH Stock Standard, 10 x 50 mL FDA UDI

Identifiers

Catalog Number
80-4060P10K FDA UDI
Primary DI / UDI-DI
00725609000168 FDA UDI
510(k) Number
K970277 FDA UDI
FDA Product Code
KQP FDA UDI
GMDN Term
Galactose-1-phosphate uridyl transferase IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1315 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: Galactose-1-phosphate uridyl transferase IVD, calibrator

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

Similar devices

Also classified as Galactose-1-phosphate uridyl transferase IVD, calibrator.

Cleared under the same submission

K970277 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 70b11e8e-fb07-4b9d-8383-1335319a2341 35 fields · synced May 30, 2026