EU0200080001

Organization name

BGI EUROPE A/S

SRN

DK-MF-000014089

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Caution, risk of crushing hands. When opening or closing the solvent manager, sample manager, and column oven doors, operate carefully to avoid crushing hands.
• CW008

  Be cautious of biohazards. When using biohazardous samples and reagents, be sure to wear gloves, lab gowns to prevent infection, and safety glasses if necessary. Be sure to follow local regulations for hazard assessment, control and handling.

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Trade name

not provided

UDI-DI code

05744003510146

Basic UDI-DI

574400351EU0200080001RZ

Reference / catalog number

EU0200080001

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The BGI LMSQ-1000 liquid chromatography tandem mass spectrometer is designed based on a combination of both chromatography and mass spectrometry technique, which is intended to be used for the qualitative and quantitative determination of the human derived biological specimens, including analytes such as whole blood, plasma, serum, urine , saliva , hair, etc. for the detecting endogenous and exogenous compounds. Based on chromatography and mass spectrum technology, the analysis of target compounds by Ultra-high performance liquid chromatography (UPLC) after a preliminary separation at atmospheric pressure under the action of ion source or electrospray ion source into charged ions, under the action of charged ions in the air and electric field through the sample cone and the transmission rod, through radio frequency voltage control transmission rod, enter the Q1 quadrupole. The Q1 quadrupole screens the target ions, and the screened ions enter the collision reaction pool and react with the reaction gas to convert into fragments. The fragments enter Q2 quadrupole and are screened in Q2 quadrupole. The screened daughter ions enter the detector to generate the final detection signal.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0201050299HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - OTHER