LLL

Product Code: LLL


Products Classified as LLL

3035Extractable Antinuclear Antibody, Antigen And ControlAntinuclear Antibody Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3035Extractable Antinuclear Antibody, Antigen And ControlAntinuclear Antibody Immunological Test System.

FDA Consensus Standards

Extractable Antinuclear Antibody, Antigen And Control [21709]21 CFR §866.5100 🔎

Pre-market Notifications for LLL

K190710EliA SymphonyS ImmunoassayPhadia AB
K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.
K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsINOVA DIAGNOSTICS, INC.
K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, And QUANTA Flash Jo-1 CiontrolsINOVA DIAGNOSTICS, INC.
K142781ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISAIMMCO DIAGNOSTICS, INC.
K141328QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLSINOVA DIAGNOSTICS, INC.
K141210QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLSINOVA DIAGNOSTICS, INC.
K122923QUANTA FLASH ENA7INOVA DIAGNOSTICS, INC.
K113143IMMULISA SCI-70 ANTIBODY ELISAIMMCO DIAGNOSTICS, INC.
K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)EUROIMMUN US
K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISBIOMEDICAL DIAGNOSTICS (BMD) SA
K072149ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01PHADIA US INC.
K053653FIDIS CONNECTIVE 10, MODEL MX006BIOMEDICAL DIAGNOSTICS (BMD) SA
K050286FIDIS CONNECTIVE 8BIOMEDICAL DIAGNOSTICS (BMD) SA
K043067ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400BIOARRAY SOLUTIONS LTD

Global Unique Device Identification Database

00613745054896Extractable Antinuclear Antibody, Antigen And Control
00613745054254Extractable Antinuclear Antibody, Antigen And Control
00817273020129Extractable Antinuclear Antibody, Antigen And Control
00817273020112Extractable Antinuclear Antibody, Antigen And Control
00817273020105Extractable Antinuclear Antibody, Antigen And Control
00817273020099Extractable Antinuclear Antibody, Antigen And Control
00817273020082Extractable Antinuclear Antibody, Antigen And Control
00817273020075Extractable Antinuclear Antibody, Antigen And Control
00817273020068Extractable Antinuclear Antibody, Antigen And Control
00817273020051Extractable Antinuclear Antibody, Antigen And Control
00817273020044Extractable Antinuclear Antibody, Antigen And Control
00816879020380Extractable Antinuclear Antibody, Antigen And Control
00816879020342Extractable Antinuclear Antibody, Antigen And Control
00816879020335Extractable Antinuclear Antibody, Antigen And Control
00816879020304Extractable Antinuclear Antibody, Antigen And Control

Maude Adverse Events

BD ECLIPSEBD2011-01-04
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