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Spotcheck

FDA UDI

Class II (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence FDA UDI
Device Name
G6PD 25 Hour Reagent Kit FDA UDI
Model / Reference
80-3500-13K FDA UDI
Description
G6PD 25 Hour Reagent Kit FDA UDI

Identifiers

Catalog Number
80-3500-13K FDA UDI
Primary DI / UDI-DI
00725609000038 FDA UDI
510(k) Number
K990957 FDA UDI
FDA Product Code
JBL FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7360 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: Red cell glucose-6-phosphate dehydrogenase (G6PD) 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 Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence.

Cleared under the same submission

K990957 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 ada5b20a-4042-4585-b3ad-dcf07111a4fd 35 fields · synced May 31, 2026