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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
Glucose IVD, calibrator FDA UDI
Device Name
Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures. 1 x 15ml FDA UDI
Model / Reference
G7518-STD FDA UDI
Description
Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures. 1 x 15ml FDA UDI

Identifiers

Catalog Number
G7518-STD FDA UDI
Primary DI / UDI-DI
00811727011299 FDA UDI
510(k) Number
K810674 FDA UDI
FDA Product Code
CGA FDA UDI
GMDN Term
Glucose IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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: Glucose 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 Glucose IVD, calibrator.

Cleared under the same submission

K810674 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 27a7bc84-939b-4425-98f1-13ad43aa97b1 36 fields · synced May 30, 2026