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Pointe Scientific Ammonia

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
POINTE SCIENTIFIC AMMONIA FDA UDI
Generic Name
Ammonia IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only. FDA UDI
Model / Reference
A7553-34 FDA UDI
Description
This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only. FDA UDI

Identifiers

Catalog Number
A7553-34 FDA UDI
Primary DI / UDI-DI
00811727010247 FDA UDI
510(k) Number
K864706 FDA UDI
FDA Product Code
JIF FDA UDI
GMDN Term
Ammonia IVD, kit, enzyme spectrophotometry 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, kit, enzyme spectrophotometry

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

Similar devices

Also classified as Ammonia IVD, kit, enzyme spectrophotometry.

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 99d3ee37-4a06-490b-aeeb-1b17f98472b9 37 fields · synced May 30, 2026