| UCP RAPID DRUG SCREENING TESTS (K050540) | Ucp Biosciences, Inc. | 2005-04-29 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) (K050682) | Bio-Rad Laboratories, Inc. | 2005-04-29 |
| ONTRAK TESTCARD 9 (K050321) | Varian, Inc. | 2005-04-18 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
| QMS VANCOMYCIN (K050419) | Seradyn, Inc. | 2005-04-01 |
| SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT (K043556) | Beckman Coulter, Inc. | 2005-03-28 |
| TRIAGE TOX DRUG SCREEN CONTROLS (K050037) | Biosite Incorporated | 2005-03-22 |
| ONLINE DAT PROPOXYPHENE PLUS (K043303) | Roche Diagnostics Corp. | 2005-03-11 |
| ON CALL MULTI-DRUG HOME TEST (K050050) | ACON Laboratories, Inc. | 2005-03-11 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (K050186) | Ameditech, Inc. | 2005-03-04 |
| MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338) | Akers Biosciences, Inc. | 2005-03-04 |
| TRIAGE TOX DRUG SCREEN (K043242) | Biosite Incorporated | 2005-02-28 |
| ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE (K043507) | ACON Laboratories, Inc. | 2005-02-25 |
| ALCOHAWK PRECISION (K043188) | Q3 Innovations, LLC | 2005-02-09 |
| ADVIA IMS VALPROIC ACID METHOD (K042807) | Bayer Healthcare, LLC | 2005-02-08 |
| ADVIA IMS CARBAMAZEPINE METHOD (K042808) | Bayer Healthcare, LLC | 2005-02-08 |
| QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (K043051) | Phamatech, Inc. | 2005-02-07 |
| ONLINE DAT BENZODIAZEPINES PLUS (K043327) | Roche Diagnostics Corp. | 2005-02-07 |
| VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386) | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |
| VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043384) | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |
| ROCHE AMPLICHIP CYP450 TEST (K043576) | Roche Molecular Systems, Inc. | 2005-01-10 |
| EMIT II PLUS ECSTASY ASSAY (K043028) | Dade Behring, Inc. | 2005-01-07 |
| ACETAMINOPHEN-SL ASSAY (K042330) | Diagnostic Chemicals , Ltd. | 2005-01-07 |
| VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479) | Ortho-Clinical Diagnostics, Inc. | 2005-01-06 |
| ONLINE DAT BARBITURATES PLUS (K043211) | Roche Diagnostics Corp. | 2004-12-29 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (K042975) | Ameditech, Inc. | 2004-12-29 |
| PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X (K043167) | Phamatech, Inc. | 2004-12-29 |
| SALICYLATE-SL ASSAY (K042329) | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011) | Roche Molecular Systems, Inc. | 2004-12-23 |
| VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476) | Ortho-Clinical Diagnostics, Inc. | 2004-12-01 |
| VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III (K042520) | Ortho-Clinical Diagnostics, Inc. | 2004-11-30 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) (K042865) | Bio-Rad | 2004-11-24 |
| IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) (K041747) | Lifepoint,Inc | 2004-11-24 |
| IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) (K041746) | Lifepoint,Inc | 2004-11-23 |
| RANDOX CANNABINOIDS ASSSAY (K041142) | Randox Laboratories, Ltd. | 2004-11-23 |
| RANDOX BARBITURATE ASSAY (K041143) | Randox Laboratories, Ltd. | 2004-11-05 |
| 'RAPIDTEC 4' TEST (K041712) | American Bio Medica Corp. | 2004-11-03 |
| RANDOX OPIATES ASSAY (K041144) | Randox Laboratories, Ltd. | 2004-11-03 |
| EMIT CAFFEINE ASSAY (K042407) | Dade Behring, Inc. | 2004-10-28 |
| ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE (K041822) | ACON Laboratories, Inc. | 2004-09-16 |
| ACON TRI-FECT DRUG SCREEN TEST DEVICE (K041743) | ACON Laboratories, Inc. | 2004-09-09 |
| ACON MULTI-CLIN DRUG SCREEN TEST DEVICE (K041685) | ACON Laboratories, Inc. | 2004-08-30 |
| TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (K032291) | Linde Medical Sensors AG | 2004-08-24 |
| DC-ACETA/SAL CONTROLS (K041666) | Diagnostic Chemicals , Ltd. | 2004-08-17 |
| ALCOMATE, MODEL CA2000 (K041334) | Khn Solutions, LLC | 2004-08-11 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
| ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY (K041221) | Accu-Stat Diagnostics, Inc. | 2004-07-13 |
| LIQUICHEK WHOLE BLOOD VOLATILES CONTROL (K041561) | Bio-Rad | 2004-07-06 |
| CEDIA BUPRENORPHINE ASSAY (K040316) | Microgenics Corp. | 2004-06-23 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (K040257) | Quest Diagnostics, Inc. | 2004-06-14 |
| RANDOX AMIKACIN (K033884) | Randox Laboratories, Ltd. | 2004-06-09 |
| COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT (K033743) | Cozart Bioscience , Ltd. | 2004-06-03 |
| MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT (K040758) | Microgenics Corp. | 2004-05-28 |
| DRI OXYCODONE ASSAY (K040411) | Microgenics Corp. | 2004-05-27 |
| BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885) | Lin-Zhi International, Inc. | 2004-05-19 |
| FIRST SIGN DRUG OF ABUSE SCREENING TEST (K032575) | W.H.P.M., Inc. | 2004-05-19 |
| ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445) | ACON Laboratories, Inc. | 2004-05-19 |
| MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 (K033566) | Rapid Diagnostics, Inc. | 2004-05-17 |
| AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST (K040464) | Amedica Biotech, Inc. | 2004-05-17 |
| RANDOX AMPHETAMINE CLASS ASSAY (K040350) | Randox Laboratories, Ltd. | 2004-05-12 |
| RANDOX METHADONE ASSAY (K040570) | Randox Laboratories, Ltd. | 2004-05-10 |
| ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE (K040629) | Accu-Stat Diagnostics, Inc. | 2004-05-05 |
| ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE (K040274) | ACON Laboratories, Inc. | 2004-05-03 |
| HEMOSONIC 200HEMODYNAMIC MONITOR (K040802) | Arrow Intl., Inc. | 2004-04-28 |
| URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE (K040133) | Dade Behring, Inc. | 2004-04-08 |
| CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) (K033866) | Lin-Zhi International, Inc. | 2004-04-07 |
| MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 (K040203) | Branan Medical Corp. | 2004-03-25 |
| AMEDITECH IMMU TEST DRUG SCREEN PANEL (K040092) | Ameditech, Inc. | 2004-03-08 |
| LABONE COCAINE METABOLITE MICRO-PLATE EIA (K040198) | Labone, Inc. | 2004-03-05 |
| VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 (K033879) | Maine Standards Co. | 2004-02-27 |
| DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D (K033809) | Dade Behring, Inc. | 2004-02-20 |
| ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE (K032903) | ACON Laboratories, Inc. | 2004-02-17 |
| ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE (K033047) | ACON Laboratories, Inc. | 2004-02-17 |
| LABONE MICRO-PLATE COTININE EIA (K033601) | Labone, Inc. | 2004-02-10 |
| URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A (K033713) | Dade Behring, Inc. | 2004-02-09 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924) | Bio-Rad Laboratories, Inc. | 2004-02-03 |
| ONTRAK TESTCUP II AND ONSITE CUPKIT (K033902) | Varian, Inc. | 2004-01-20 |
| ROCHE ONLINE TDM LIDOCAINE (K032334) | Roche Diagnostics Corp. | 2004-01-12 |
| ROCHE ONLINE TDM QUINIDINE (K032332) | Roche Diagnostics Corp. | 2004-01-12 |
| VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK (K033659) | Varian, Inc. | 2004-01-06 |
| DIAZYME LITHIUM ENZYMATIC ASSAY KIT (K033360) | General Atomics | 2003-12-23 |
| RANDOX EVIDENCE (K030360) | Randox Laboratories, Ltd. | 2003-12-23 |
| ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) (K033094) | Lin-Zhi International, Inc. | 2003-12-19 |
| INSTAREAD LITHIUM SYSTEM (K031579) | Akers Laboratories, Inc. | 2003-12-19 |
| PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K033306) | Roche Diagnostics Corp. | 2003-12-15 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE (K033299) | ACON Laboratories, Inc. | 2003-12-12 |
| LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 (K033366) | Bio-Rad | 2003-12-12 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) (K033404) | Bio-Rad | 2003-12-12 |
| PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (K033246) | Roche Diagnostics Corp. | 2003-12-02 |
| CEDIA VANCOMYCIN ASSAY (K032811) | Microgenics Corp. | 2003-11-24 |
| BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007) | Bayer Diagnostics Corp. | 2003-11-14 |
| PROFILE -ER (K033334) | Medtox Diagnostics, Inc. | 2003-11-10 |
| BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) (K032764) | Lin-Zhi International, Inc. | 2003-11-03 |
| DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 (K032564) | Dade Behring, Inc. | 2003-10-31 |
| DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (K032573) | Dade Behring, Inc. | 2003-10-31 |
| AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (K031497) | Amedica Biotech, Inc. | 2003-10-17 |
| MICROGENICS CYCLOSPORINE CONTROL KIT (K032842) | Microgenics Corp. | 2003-10-17 |
| PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS (K033165) | Roche Diagnostics Corp. | 2003-10-14 |
| ONLINE TDM AMIKA (K032279) | Roche Diagnostics Corp. | 2003-10-10 |
| METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) (K031797) | Lin-Zhi International, Inc. | 2003-10-10 |