| DIADEXUS PLAC TEST (K050523) | Diadexus, Inc. | 2005-06-15 |
| QUANTA LITE SP100 ELISA (K050662) | Inova Diagnostics, Inc. | 2005-06-13 |
| MODIFICATION TO: UNICAP SPECIFIC IGE (K051218) | Pharmacia Diagnostics AB | 2005-06-09 |
| DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 (K050713) | Good Biotech Corp. | 2005-06-06 |
| AESKULISA TTG A AND AESKULISA TTG G (K042644) | Aesku, Inc. | 2005-06-01 |
| ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 (K043067) | Bioarray Solutions, Ltd. | 2005-05-31 |
| LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (DEN050002) | Wako Chemicals USA, Inc. | 2005-05-19 |
| QUANTIA A1-AT (K050596) | Biokit, S.A. | 2005-05-13 |
| QUANTA PLEX ANCA PROFILE (K050715) | Inova Diagnostics, Inc. | 2005-05-12 |
| CARDIOMPO TEST (K050029) | Prognostix, Inc. | 2005-05-10 |
| TAG-IT CYSTIC FIBROSIS KIT (DEN050004) | Tm Bioscience Corporation | 2005-05-09 |
| PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119) | Beckman Coulter, Inc. | 2005-05-06 |
| N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (K050665) | Dade Behring, Inc. | 2005-05-02 |
| QUANTIA LA(A) (K050487) | Biokit, S.A. | 2005-04-26 |
| VARELISA RECOMBI ANA PROFILE, MODEL 18496 (K050625) | Sweden Diagnostics (Germany) GmbH | 2005-04-26 |
| ARIOL HER-2/NEU FISH (K043519) | Applied Imaging Corp. | 2005-04-25 |
| MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (K050576) | Good Biotech Corp. | 2005-04-21 |
| PAXGENE BLOOD RNA SYSTEM (DEN050003) | Preanalytix GmbH | 2005-04-18 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K050245) | Veridex, LLC | 2005-03-15 |
| AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA (K043433) | Hycor Biomedical , Ltd. | 2005-03-07 |
| ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272) | ACON Laboratories, Inc. | 2005-02-28 |
| N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) (K042735) | Dade Behring, Inc. | 2005-02-15 |
| TINA-QUANT IGG GEN.2 (K050113) | Roche Diagnostics Corp. | 2005-02-08 |
| ARCHITECT STAT MYO IMMUNOASSAY (K042924) | Fisher Diagnostics | 2005-01-24 |
| CYTOVISION FOR CEP XY (K042542) | Applied Imaging Corp. | 2005-01-10 |
| ARCHITECT CA 15-3 ASSAY (K042732) | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| QUANTEX MYOGLOBIN (K042982) | Instrumentation Laboratory CO | 2004-12-22 |
| BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 (K041658) | Bio-Rad Laboratories, Inc. | 2004-12-20 |
| KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT (K042248) | Kronus Market Development Associates, Inc. | 2004-12-17 |
| VYSIS AUTOVYSION SYSTEM (DEN040010) | Vysis | 2004-12-13 |
| K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241) | Kamiya Biomedical Co. | 2004-12-10 |
| VARELISA SM ANTIBODIES, MODEL 18296 (K042629) | Sweden Diagnostics (Germany) GmbH | 2004-12-08 |
| BINDING SITE IGG SUBLCASS OLYMPUS KITS (K042152) | The Binding Site | 2004-11-22 |
| RHIGENE HEP-ANA TEST SYSTEM (K042680) | Corgenix, Inc. | 2004-11-19 |
| VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN (K042477) | Ortho-Clinical Diagnostics, Inc. | 2004-11-19 |
| ARCHITECT CA 125 II ASSAY (K042731) | Fujirebio Diagnostics,Inc. | 2004-11-19 |
| VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II (K042643) | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC (K042475) | Ortho-Clinical Diagnostics, Inc. | 2004-11-10 |
| MININEPH HUMAN RHEUMATOID FACTOR KIT (K041891) | The Binding Site | 2004-11-05 |
| TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485) | Roche Diagnostics Corp. | 2004-10-29 |
| IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (K041102) | Immco Diagnostics, Inc. | 2004-10-26 |
| IBD-SCAN (K042071) | Techlab, Inc. | 2004-10-20 |
| VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494) | Ortho-Clinical Diagnostics | 2004-10-19 |
| WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (K041155) | Stanbio Laboratory | 2004-10-14 |
| AESKULISA DS DNA G (K041628) | Aesku Diagnostics | 2004-10-14 |
| ATHENA MULTI-LYTE ANA-II TEST SYSTEM (K042416) | Zeus Scientific, Inc. | 2004-10-08 |
| FIDIS CELIAC (K041002) | Biomedical Diagnostics S.A. | 2004-09-24 |
| QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE (K042442) | Orion Diagnostica, OY | 2004-09-24 |
| VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS (K041863) | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 |
| VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS (K041799) | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K041668) | Olympus America, Inc. | 2004-08-19 |
| CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (K041173) | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| VARELISA GLIADIN IGG ANTIBODIES (K041357) | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (K041174) | Sweden Diagnostics (Germany) GmbH | 2004-07-19 |
| BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS (K040466) | The Binding Site | 2004-07-16 |
| VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (K041354) | Sweden Diagnostics (Germany) GmbH | 2004-07-16 |
| AESKULISA ENA 6 S (K041753) | Aesku Diagnostics | 2004-07-14 |
| VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 (K041043) | Pharmacia Deutschland GmbH | 2004-07-02 |
| QUANTA LITE GP210 ELISA (K040885) | Inova Diagnostics, Inc. | 2004-06-25 |
| N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (K040241) | Genzyme Corp. | 2004-06-25 |
| AESKULISA ANA HEP-2 (K040953) | Aesku, Inc. | 2004-06-23 |
| CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (K040579) | Cholestech Corp. | 2004-06-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322) | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 |
| BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (K040030) | Biocheck, Inc. | 2004-06-16 |
| VARELISA MPO ANCA, MODEL 17648/17696 (K041040) | Sweden Diagnostics (Germany) GmbH | 2004-06-16 |
| VARELISA HISTONE ANTIBODIES, MODEL 16496 (K040810) | Pharmacia Deutschland GmbH | 2004-05-14 |
| VARELISA SSDNA ANTIBODIES, MODEL 14896 (K040811) | Pharmacia Deutschland GmbH | 2004-05-13 |
| AESKULISA CARDIOLIPIN AGM (K040463) | Aesku, Inc. | 2004-05-12 |
| VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (K040451) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (K040449) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (K040450) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (K040452) | Pharmacia Deutschland GmbH | 2004-05-11 |
| QUANTEX FERRITIN (K040879) | Instrumentation Laboratory CO | 2004-05-10 |
| ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM (K040111) | Zeus Scientific, Inc. | 2004-04-05 |
| MESACUP TEST PR-3 (K040711) | Rhigene, Inc. | 2004-04-02 |
| ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM (K033977) | Zeus Scientific, Inc. | 2004-03-22 |
| BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN (K033454) | Brahms Diagnostica, LLC | 2004-03-22 |
| MESACUP TEST MPO, MODEL 11053 (K040586) | Rhigene, Inc. | 2004-03-22 |
| IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (K032860) | Immco Diagnostics, Inc. | 2004-03-18 |
| IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) (K032850) | Immco Diagnostics, Inc. | 2004-03-18 |
| EL-ANA PROFILES: ANTI-CHROMATIN (K040291) | Theratest Laboratories, Inc. | 2004-03-11 |
| FREELITE HUMAN KAPPA AND LAMBDA KITS (K040009) | The Binding Site, Ltd. | 2004-03-11 |
| ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434) | Roche Diagnostics Corp. | 2004-03-10 |
| ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431) | Roche Diagnostics Corp. | 2004-03-10 |
| ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435) | Roche Diagnostics Corp. | 2004-03-10 |
| LACRYTEST (K034057) | Adiatec SA | 2004-03-09 |
| QUANTA PLEX SLE PROFILE 8 (K040160) | Inova Diagnostics, Inc. | 2004-03-08 |
| IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA (K040095) | Immco Diagnostics, Inc. | 2004-03-05 |
| MESACUP-2 TEST CENP-B (K040200) | Rhigene, Inc. | 2004-03-04 |
| ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM (K033802) | Zeus Scientific, Inc. | 2004-02-27 |
| MODIFICATION TO DIADEXUS PLAC TEST (K040101) | Diadexus, Inc. | 2004-02-05 |
| BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036) | Beckman Coulter, Inc. | 2004-02-03 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811) | The Binding Site, Ltd. | 2004-01-30 |
| N HIGH SENSITIVITY CRP (K033908) | Dade Behring, Inc. | 2004-01-22 |
| MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (K033982) | Vysis | 2004-01-22 |
| DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692) | Dako A/S | 2004-01-22 |
| CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM (DEN040001) | Advanced Diagnostic Systems | 2004-01-21 |
| AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA (K033744) | Hycor Biomedical , Ltd. | 2004-01-20 |
| IBL C3D-CIC EIA TEST (K032796) | Ibl GmbH | 2004-01-13 |