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POINTE SCIENTIFIC Ammonia Standard 1

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
POINTE SCIENTIFIC Ammonia Standard 1 FDA UDI
Generic Name
Ammonia IVD, calibrator FDA UDI
Device Name
The Ammonia Standards are intended for the calibration of ammonia assays. FDA UDI
Model / Reference
A7553-STD100 FDA UDI
Description
The Ammonia Standards are intended for the calibration of ammonia assays. FDA UDI

Identifiers

Catalog Number
A7553-STD100 FDA UDI
Primary DI / UDI-DI
00811727010261 FDA UDI
510(k) Number
K864706 FDA UDI
FDA Product Code
JIF FDA UDI
GMDN Term
Ammonia IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1065 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: Ammonia IVD, calibrator

POINTE SCIENTIFIC Ammonia Standard 1 by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ammonia IVD, calibrator.

Cleared under the same submission

K864706 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 56ccb903-e5a7-4aa2-a405-5450f98cba83 37 fields · synced May 30, 2026