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Nh3

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
NH3 FDA UDI
Generic Name
Ammonia IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
For the quantitative in vitro determination of Ammonia in plasma. FDA UDI
Model / Reference
AM3979 FDA UDI
Description
For the quantitative in vitro determination of Ammonia in plasma. FDA UDI

Identifiers

Catalog Number
AM3979 FDA UDI
Primary DI / UDI-DI
05055273200270 FDA UDI
510(k) Number
K030873 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

Yes

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

Nh3 by Randox Laboratories, Ltd. — 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

K030873 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 4d9ae5c7-4ab1-45f8-a0d7-7294d6df48d2 37 fields · synced May 30, 2026