Devices

DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA

Model / Serial
UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution and US. Nationwide
Product Description
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. || Product Usage: || The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
Manufacturer
Euro Diagnostica AB
1 Event
- Recall of DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA

Manufacturer

Euro Diagnostica AB

Manufacturer Address
Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
Manufacturer Parent Company (2017)
C&P Investors Limited
Source
USFDA

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