| K190710 | EliA SymphonyS Immunoassay | Phadia AB |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | INOVA DIAGNOSTICS, INC. |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, And QUANTA Flash Jo-1 Ciontrols | INOVA DIAGNOSTICS, INC. |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | IMMCO DIAGNOSTICS, INC. |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | INOVA DIAGNOSTICS, INC. |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | INOVA DIAGNOSTICS, INC. |
| K122923 | QUANTA FLASH ENA7 | INOVA DIAGNOSTICS, INC. |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | IMMCO DIAGNOSTICS, INC. |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | EUROIMMUN US |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | BIOMEDICAL DIAGNOSTICS (BMD) SA |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | PHADIA US INC. |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | BIOMEDICAL DIAGNOSTICS (BMD) SA |
| K050286 | FIDIS CONNECTIVE 8 | BIOMEDICAL DIAGNOSTICS (BMD) SA |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | BIOARRAY SOLUTIONS LTD |
| 00613745054896 | Extractable Antinuclear Antibody, Antigen And Control |
| 00613745054254 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020129 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020112 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020105 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020099 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020082 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020075 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020068 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020051 | Extractable Antinuclear Antibody, Antigen And Control |
| 00817273020044 | Extractable Antinuclear Antibody, Antigen And Control |
| 00816879020380 | Extractable Antinuclear Antibody, Antigen And Control |
| 00816879020342 | Extractable Antinuclear Antibody, Antigen And Control |
| 00816879020335 | Extractable Antinuclear Antibody, Antigen And Control |
| 00816879020304 | Extractable Antinuclear Antibody, Antigen And Control |