| DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 (K033525) | Dade Behring, Inc. | 2004-01-12 |
| REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (K034013) | Corgenix, Inc. | 2004-01-08 |
| GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 (K033038) | Beckman Coulter, Inc. | 2003-12-29 |
| IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA (K032571) | Immco Diagnostics, Inc. | 2003-12-24 |
| MESACUP-2 TEST JO-1, MODEL 10756 (K033528) | Rhigene, Inc. | 2003-12-22 |
| QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 (K032663) | Instrumentation Laboratory CO | 2003-12-19 |
| IMMUNETECH TOTAL IGE SYSTEM (K032251) | Immunetech Corporation | 2003-12-19 |
| AESKULISA ANA 8PRO (K032469) | Aesku, Inc. | 2003-12-16 |
| INTERLAB IMMUNOFIXATION TEST(S) (K033187) | Interlab S.R.L. | 2003-11-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300) | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 |
| HYDRAGEL CSF ISOFOCUSING KITS (K033277) | Morax | 2003-11-04 |
| REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (K032868) | Corgenix, Inc. | 2003-10-14 |
| ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL (K031607) | Orion Diagnostica, Div. Orion Corp. | 2003-10-10 |
| EXTENDED RANGE HS CRP KIT, CAT NO:9200 (K030044) | Reference Diagnostics, Inc. | 2003-09-30 |
| BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT (K032240) | The Binding Site, Ltd. | 2003-09-29 |
| RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (K031308) | Rhigene, Inc. | 2003-09-26 |
| BINDAZYME CLQ CIC EIA KIT (K031563) | The Binding Site, Ltd. | 2003-09-10 |
| TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT (K032134) | Kronus Market Development Associates, Inc. | 2003-09-10 |
| MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K032535) | Roche Diagnostics Corp. | 2003-09-10 |
| IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA (K030701) | Immco Diagnostics, Inc. | 2003-09-09 |
| IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA (K030702) | Immco Diagnostics, Inc. | 2003-09-09 |
| ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (K031857) | Bayer Diagnostics Corp. | 2003-09-04 |
| IBL C1Q-CIC CIA TEST (K032254) | Ibl GmbH | 2003-08-29 |
| N LATEX IGM (K032014) | Dade Behring, Inc. | 2003-08-07 |
| SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035) | Beckman Coulter, Inc. | 2003-08-07 |
| TINA-QUANT CRP (LATEX) (K032336) | Roche Diagnostics Corp. | 2003-08-05 |
| DIADEXUS PLAC TEST (K030477) | Diadexus, Inc. | 2003-07-18 |
| FERRITIN GENERATION 2 (K031650) | Roche Diagnostics Corp. | 2003-07-17 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016) | The Binding Site, Ltd. | 2003-07-15 |
| REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 (K031208) | Corgenix, Inc. | 2003-07-07 |
| C-REACTIVE PROTEIN (CRP) (K030899) | Abbott Laboratories | 2003-07-02 |
| QUANTA PLEX ENA PROFILE 6 (K031450) | Inova Diagnostics, Inc. | 2003-06-25 |
| BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393) | Bayer Healthcare, LLC | 2003-06-24 |
| DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M (K031177) | Axis-Shield Diagnostics, Ltd. | 2003-06-19 |
| WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET (K024280) | Wako Chemicals USA, Inc. | 2003-06-06 |
| CRP-LATEX (II)X2 SEIKEN ASSAY KIT (K030545) | Denka Seiken Co., Ltd. | 2003-06-02 |
| TPSA FLEX REAGENT CARTRIDGE (K031343) | Dade Behring, Inc. | 2003-05-15 |
| AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (K030775) | Immuno Concepts, N.A. , Ltd. | 2003-05-12 |
| ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270) | Beckman Coulter, Inc. | 2003-05-06 |
| ACCESS OV MONITOR ASSAY (K031297) | Beckman Coulter, Inc. | 2003-05-02 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269) | Beckman Coulter, Inc. | 2003-05-02 |
| ANA DETECT (K030929) | Orgentec Diagnostika GmbH | 2003-05-02 |
| AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA (K030741) | Hycor Biomedical , Ltd. | 2003-05-01 |
| MICROALBUMIN REAGENT SET AND CALIBRATORS (K023860) | Pointe Scientific, Inc., | 2003-04-28 |
| QUANTA PLEX ENA PROFILE 5 (K030681) | Inova Diagnostics, Inc. | 2003-04-24 |
| IBD-QUIK CHEK (K030704) | Techlab, Inc. | 2003-04-21 |
| BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (K030238) | The Binding Site, Ltd. | 2003-03-24 |
| AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA (K030397) | Hycor Biomedical , Ltd. | 2003-03-21 |
| CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) (K030590) | Hitachi Chemical Diagnostics, Inc. | 2003-03-21 |
| VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 (K030626) | Ortho-Clinical Diagnostics, Inc. | 2003-03-18 |
| IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210) | Beckman Coulter, Inc. | 2003-02-24 |
| BIORAPID MONONUCLEOSIS (K030215) | Instrumentation Laboratory CO | 2003-02-24 |
| SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (K024162) | Helena Laboratories | 2003-02-19 |
| N LATEX IGA (K024038) | Dade Behring, Inc. | 2003-02-13 |
| EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (K024151) | Theratest Laboratories, Inc. | 2003-02-06 |
| SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (K023593) | Quest Intl., Inc. | 2003-02-06 |
| OLYMPUS FERRITIN REAGENT (K030124) | Olympus America, Inc. | 2003-02-06 |
| THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (K024031) | Theratest Laboratories, Inc. | 2003-02-06 |
| K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR (K023828) | Kamiya Biomedical Co. | 2003-02-04 |
| BAYER ADVIA CENTAUR HER-2/NEU ASSAY (K024017) | Bayer Corp. | 2003-01-30 |
| FREELITE HUMAN LAMBDA FREE KIT (K023131) | The Binding Site, Ltd. | 2003-01-21 |
| FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER (K023009) | The Binding Site, Ltd. | 2003-01-21 |
| LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (K024218) | Bio-Rad | 2003-01-17 |
| LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (K024220) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (K024232) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 (K024222) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 (K024217) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 (K024224) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 (K024227) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 (K024225) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 (K024229) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 (K024230) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 (K024221) | Bio-Rad | 2003-01-15 |
| LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (K024219) | Bio-Rad | 2003-01-15 |
| RHEUMATOID FACTOR (RF) (K024067) | Abbott Laboratories | 2003-01-15 |
| LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 (K024231) | Bio-Rad | 2003-01-13 |
| LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (K024223) | Bio-Rad | 2003-01-13 |
| LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 (K024226) | Bio-Rad | 2003-01-10 |
| SERAQUEST ANTI-THYROGLOBULIN (K023592) | Quest Intl., Inc. | 2003-01-06 |
| MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT (K024195) | Corgenix, Inc. | 2003-01-03 |
| REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (K024196) | Corgenix, Inc. | 2003-01-03 |
| AIA-PACK CA 19-9 (K023239) | Tosoh Corp. | 2002-12-23 |
| PAROS CRP (K022690) | Horiba, Ltd. | 2002-12-23 |
| HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS (K023269) | Instrumentation Laboratory CO | 2002-12-23 |
| ST AIA-PACK CA 19-9 (K023240) | Tosoh Corp. | 2002-12-23 |
| AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA (K022945) | Hycor Biomedical, Inc. | 2002-12-18 |
| AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA (K022944) | Hycor Biomedical, Inc. | 2002-12-18 |
| ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893) | Tosoh Medics, Inc. | 2002-12-18 |
| IMMULITE 2000 ALLERGEN-SPECIFIC IGE (K023152) | Diagnostic Products Corp. | 2002-12-17 |
| ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894) | Tosoh Medics, Inc. | 2002-12-17 |
| PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177) | Bayer Diagnostics Corp. | 2002-12-17 |
| COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288) | Bayer Corp. | 2002-12-17 |
| K-ASSAY LP(A) CONTROLS (K023853) | Kamiya Biomedical Co. | 2002-12-13 |
| ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY (K023597) | Beckman Coulter, Inc. | 2002-12-11 |
| ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (K023891) | Tosoh Medics, Inc. | 2002-12-06 |
| ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 (K022176) | Orion Diagnostica, Div. Orion Corp. | 2002-12-03 |
| CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022329) | Bayer Diagnostics Corp. | 2002-11-27 |
| VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM (K022800) | Hyperion, Inc. | 2002-11-25 |
| VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 (K023433) | Pharmacia Diagnostics GmbH & Co. KG | 2002-11-13 |
| CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178) | Bayer Diagnostics Corp. | 2002-11-12 |