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Pointe Scientific, Inc.

FDA UDI

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent FDA UDI
Device Name
Glucose-6-Phosphate Dehydrogenase (G6PD) Lyse. Size: 1 x 100 mL FDA UDI
Model / Reference
G7583-LYS FDA UDI
Description
Glucose-6-Phosphate Dehydrogenase (G6PD) Lyse. Size: 1 x 100 mL FDA UDI

Identifiers

Catalog Number
G7583-LYS FDA UDI
Primary DI / UDI-DI
00811727014511 FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent FDA UDI

Classification

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, reagent

Pointe Scientific, Inc. by Pointe Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent.

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 163ceabc-72e7-4da7-8751-84e6f9f98203 36 fields · synced May 30, 2026