LJM

Product Code: LJM


Products Classified as LJM

3030Antinuclear Antibody (enzyme-labeled), Antigen, ControlsAntinuclear Antibody Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3030Antinuclear Antibody (enzyme-labeled), Antigen, ControlsAntinuclear Antibody Immunological Test System.

FDA Consensus Standards

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls [21709]21 CFR §866.5100 🔎

Pre-market Notifications for LJM

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB
K151559ImmuLisa Enhanced Centromere Antibody ELISAIMMCO DIAGNOSTICS, INC.
K140493ELIA SCL-70S IMMUNOASSAYPHADIA GMBH
K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITGOLD STANDARD DIAGNOSTICS
K131185ANA SCREEN ELISA (IGG)EUROIMMUN US
K123880QUANTA FLASH CENTROMEREINOVA DIAGNOSTICS, INC.
K083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596PHADIA US INC.
K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096SWEDEN DIAGNOSTICS (GERMANY) GMBH
K041102IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISAIMMCO DIAGNOSTICS, INC.
K040953AESKULISA ANA HEP-2AESKU, INC
K040291EL-ANA PROFILES: ANTI-CHROMATINTHERATEST LABORATORIES, INC.
K040200MESACUP-2 TEST CENP-BRHIGENE, INC.
K030929ANA DETECTORGENTEC DIAGNOSTIKA GMBH
K024031THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERETHERATEST LABORATORIES, INC.
K022018RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560RHIGENE, INC.

Global Unique Device Identification Database

00613745051895Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00613745051253Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00613745039206Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00613745039183Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00657498001288Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00850487007470Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00850487007456Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00850487007296Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00850487007272Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00850487007005Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00847817022432ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
00847817022401ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
00845714002397Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00845714000362Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
00845714000218Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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