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Pointe G6PD Reagent

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe G6PD Reagent FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
Pointe G6PD Reagent, 10 x 6ml, 1 x 120ml kit, For the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only. FDA UDI
Model / Reference
G7583-180 FDA UDI
Description
Pointe G6PD Reagent, 10 x 6ml, 1 x 120ml kit, For the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only. FDA UDI

Identifiers

Catalog Number
G7583-180 FDA UDI
Primary DI / UDI-DI
00811727014139 FDA UDI
510(k) Number
K024006 FDA UDI
FDA Product Code
JBF FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry 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

No

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 spectrophotometry

Pointe G6PD Reagent by Pointe Scientific, 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 spectrophotometry.

Cleared under the same submission

K024006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI db89b42a-bfdc-4e90-851d-a3d3a8a7c737 36 fields · synced May 30, 2026