| HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K935828) | Hemagen Diagnostics, Inc. | 1994-04-20 |
| RELISA ENA ANTIBODY SCREENING TEST SYSTEM (K935129) | Immuno Concepts, Inc. | 1994-01-31 |
| QUANTA LITE(TM) HISTONE ELISA (K934053) | Inova Diagnostics, Inc. | 1993-12-21 |
| DIASTAT ANTI-CENTROMERE KIT (K932877) | Shield Diagnostics, Ltd. | 1993-10-15 |
| ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN (K932850) | Helix Diagnostics, Inc. | 1993-09-24 |
| ENCORE ENA COMBINED EIA (K931543) | Clark Laboratories, Inc. | 1993-09-08 |
| ANTI-SS-B/LA ANTIBODY TEST (K932419) | Helix Diagnostics, Inc. | 1993-08-05 |
| ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT (K931495) | Helix Diagnostics, Inc. | 1993-07-16 |
| ELISA-DOXA COMBI-6 (K924952) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SSB (K924946) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SM/RNP (K924948) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA COMBI-4 (K924951) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SM (K924947) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DPXA SSA KIT (K924945) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SCL-70 (K924949) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA JO-1 (K924950) | Advanced Biological Products, Inc. | 1993-05-19 |
| SYNELISA JO-1 ANTIBODIES (K930281) | Elias U.S.A., Inc. | 1993-04-06 |
| SYNELISA SCL-70 ANTIBODIES (K930417) | Elias U.S.A., Inc. | 1993-04-06 |
| RHEUMELISA II JO-1 ANTIBODY TEST KIT (K930757) | Biowhittaker Molecular Applications, Inc. | 1993-03-26 |
| RHEUMELISA II SCL-70 ANTIBODY TEST KIT (K930130) | Biowhittaker Molecular Applications, Inc. | 1993-03-23 |
| QUANTA LITE(TM) JO-1 ELISA KIT (K926562) | Inova Diagnostics, Inc. | 1993-03-04 |
| EN TYPING CIE KIT FOR DIAGNOSTIC USE (K925118) | The Binding Site, Ltd. | 1993-02-02 |
| ENA SCREENING CIE KIT FOR DIAGNOSTIC USE (K924262) | The Binding Site, Ltd. | 1992-12-29 |
| QUANTA LITE(TM) SCL-70 ELISA (K924898) | Inova Diagnostics, Inc. | 1992-12-15 |
| ENCORE SM/RNP (K921870) | Clark Laboratories, Inc. | 1992-12-01 |
| IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (K924843) | General Biometrics, Inc. | 1992-12-01 |
| ENCORE SM (K921572) | Clark Laboratories, Inc. | 1992-12-01 |
| AUTOZYME (K922241) | Cambridge Life Sciences Plc. | 1992-11-30 |
| ENCORE SS-B (K922340) | Clark Laboratories, Inc. | 1992-10-16 |
| ENCORE SS-A (K922157) | Clark Laboratories, Inc. | 1992-10-13 |
| QUANTA LITE RNP ELISA (K922833) | Inova Diagnostics, Inc. | 1992-09-18 |
| QUANTA LITE SS-B ELISA (K922832) | Inova Diagnostics, Inc. | 1992-09-18 |
| QUANTA LITE ENA ELISA (K922829) | Inova Diagnostics, Inc. | 1992-09-18 |
| QUANTA LITE SS-A ELISA (K922830) | Inova Diagnostics, Inc. | 1992-09-18 |
| QUANTA LITE SM ELISA (K922831) | Inova Diagnostics, Inc. | 1992-09-18 |
| HEMAGEN ENA [JO-1] KIT (EIA METHOD) (K915420) | Hemagen Diagnostics, Inc. | 1992-04-07 |
| ANTI-ENA ANTIBODY TEST (SM) (K920385) | Immco Diagnostics, Inc. | 1992-03-30 |
| ANTI-ENA ANTIBODY TEST [SS-A (RO)] (K920383) | Immco Diagnostics, Inc. | 1992-03-30 |
| ANIT-ENA ANTIBODY TEST [SS-B (LA)] (K920384) | Immco Diagnostics, Inc. | 1992-03-30 |
| ANTI-ENA ANTIBODY TEST KIT (K920386) | Immco Diagnostics, Inc. | 1992-03-30 |
| HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K915282) | Hemagen Diagnostics, Inc. | 1992-02-12 |
| HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) (K915234) | Hemagen Diagnostics, Inc. | 1991-12-20 |
| HEMAGEN ENA SCREENING KIT (EIA METHOD) (K915058) | Hemagen Diagnostics, Inc. | 1991-12-20 |
| ANTI-DSDNA ANTIBODY TEST (K913041) | Helix Diagnostics, Inc. | 1991-11-05 |
| ANTI-JO-1 MICROASSAY (K911679) | Diamedix Corp. | 1991-09-23 |
| HEMAGEN ENA SCREENING KIT (K910232) | Hemagen Diagnostics, Inc. | 1991-03-06 |
| QUANTA LITE TM DSDNA (K903898) | Inova Diagnostics, Inc. | 1990-09-05 |
| ANTI-SCI-70 ANTIBODY TEST (K903314) | Immco Diagnostics, Inc. | 1990-08-14 |
| IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 (K902938) | General Biometrics, Inc. | 1990-08-09 |
| IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 (K903047) | General Biometrics, Inc. | 1990-08-09 |
| READS(R) ANTI-ENA (SM/RNP) TEST KIT (K901924) | Biosearch Medical Products, Inc. | 1990-05-09 |
| REAADS ANTI-SM TEST KIT (K901230) | Biosearch Medical Products, Inc. | 1990-03-23 |
| ANTI-RNP MICROASSAY (K901073) | Diamedix Corp. | 1990-03-19 |
| SERATEST ENA [SSA] KIT (K900617) | Hemagen Diagnostics, Inc. | 1990-02-23 |
| ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY (K900241) | Diamedix Corp. | 1990-02-02 |
| NOVA GEL(TM) T SM/RNP (K896459) | Inova Diagnostics, Inc. | 1989-11-20 |
| NOVA GEL(TM) T SS-A/SS-B (K896460) | Inova Diagnostics, Inc. | 1989-11-20 |
| NOVA GEL(TM) T SCL-70 (K896461) | Inova Diagnostics, Inc. | 1989-11-20 |
| NOVA GEL(TM) T JO-1 (K896462) | Inova Diagnostics, Inc. | 1989-11-20 |
| ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST (K895339) | Immco Diagnostics, Inc. | 1989-10-04 |
| NOVA GEL(TM) JO-1 (K892897) | Inova Diagnostics, Inc. | 1989-05-17 |
| NOVA LITE(TM) SA (K881341) | Inova Diagnostics, Inc. | 1988-09-22 |
| HISTONE REACTIVE ANA (K883232) | Val Tech Diagnostics, Inc. | 1988-09-07 |
| NOVA LITE(TM) AUTOANTIBODY CONTROLS (K881340) | Inova Diagnostics, Inc. | 1988-06-08 |
| NOVA GEL (TM) SCL-70 (K880897) | Inova Diagnostics, Inc. | 1988-04-21 |
| NOVA LITE(TM) ANA PLUS (K881339) | Inova Diagnostics, Inc. | 1988-04-21 |
| NOVA GEL(TM) SM/RNP (K881181) | Inova Diagnostics, Inc. | 1988-04-06 |
| NOVA LITE(TM) ANA (K880736) | Inova Diagnostics, Inc. | 1988-03-25 |
| NOVA GEL(TM) SS-A/SS-B (K880896) | Inova Diagnostics, Inc. | 1988-03-25 |
| FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES (K873708) | Whittaker Bioproducts, Inc. | 1987-11-25 |
| ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) (K871994) | Behring Diagnostics, Inc. | 1987-08-12 |
| SERATEST ENA [SS-B] KIT (K862700) | Hemagen Diagnostics, Inc. | 1986-08-19 |
| KALLESTAD SSA/SSB ENA TEST REAGENTS (K862710) | Kallestad Laboratories, Inc. | 1986-07-29 |
| SM-RNP AUTOANTIBODY TEST SYSTEM (K860428) | Immuno Concepts, Inc. | 1986-05-15 |
| SS-A/SS-B AUTOANTIBODY TEST SYSTEM (K860644) | Immuno Concepts, Inc. | 1986-03-28 |
| PHYSIO GAS ANALYZER (K843423) | Research Medical, Inc. | 1985-02-26 |
| SERATEST ENA(RNP/SM) DETERMINATION (K844743) | Seragen Diagnostics, Inc. | 1985-02-04 |
| ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY (K843978) | Behring Diagnostics, Inc. | 1984-12-18 |
| EXTRACTABLE NUCLEAR ANTIGEN ASSAY (K840221) | Zeus Scientific, Inc. | 1984-05-22 |
| ENA TEST KIT SM & RNP AUTO ANTIBODY (K831036) | Calbiochem-Behring Corp. | 1983-04-27 |
| NUCLEAR ANTIGENS (K810592) | Alpha Antigens, Inc. | 1981-10-23 |