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Pointe Scientific, Inc.

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. FDA UDI
Generic Name
Lactate IVD, calibrator FDA UDI
Device Name
Reagent intended for use as a Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. 1 x 15ml FDA UDI
Model / Reference
L7596-STD FDA UDI
Description
Reagent intended for use as a Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. 1 x 15ml FDA UDI

Identifiers

Catalog Number
L7596-STD FDA UDI
Primary DI / UDI-DI
00811727011671 FDA UDI
FDA Product Code
CFJ FDA UDI
GMDN Term
Lactate IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1440 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: Lactate IVD, calibrator

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

Similar devices

Also classified as Lactate IVD, calibrator.

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 26e8c83d-0ff8-476c-9bec-f0e02a85790e 36 fields · synced May 30, 2026