Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

Trade name

Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

UDI-DI code

06950996004442

Basic UDI-DI

B-06950996004442

Reference / catalog number

1AA15B11

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

This kit is a quantitative in vitro Flowcytometry Fluorescence test suitable for detecting the concentration of Anti-dsDNA and qualitative detecting other fourteen Autoantibodies including Anti-Nucleosome，Anti-Ribosomal P，Anti-SSA-52,Anti-SSA-60，Anti- SSB,Anti-CENPB,Anti-SCL70,Anti-RNP,Anti-AMA-M2,Anti-JO 1,Anti-Sm,Anti-Histone,Anti-PM/SCL, Anti-PCNA in human serum. The results are only for clinical reference and should not be used as conclusive evidence for the diagnosis or exclusion of diseases.

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.

• W01021499MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Please refer to the IFU.

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