Ammonia (AMM) Test Kit (Glutamate Dehydrogenase)

Trade name

Ammonia (AMM) Test Kit (Glutamate Dehydrogenase)

UDI-DI code

06971674866336

Basic UDI-DI

B-06971674866336

Reference / catalog number

R1a:25mL×3 R1b:5mL×3 R2:15mL×1（709）

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

For the in vitro quantitative detection of ammonia (AMM) content in human serum. The ammonia detection kit is used for the quantitative determination of ammonia content in human serum. Due to oxidative deamination, as well as diet and transamination of amino acids, the ammonia content in the normal human blood circulation is very low. The liver is the main organ involved in ammonia removal. A common clinical indicator of nervous system damage is an increase in blood ammonia concentration. This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results.The main method used for ammonia detection in clinical practice is the glutamate dehydrogenase method.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01010301AMMONIA

No certificate specifically references this device's Basic UDI-DI.