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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CMV IGG ELISA TEST (K915892)Gull Laboratories, Inc.1992-02-14
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666)Dako Corp.1992-02-14
EBV-VCA IGM ELISA (K915348)Pharmacia Diagnostics, Inc.1992-02-14
CLARITHROMYCIN 15MCG SENSI DISC (K920131)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-06
STREP A OIA (K915758)Biosearch Medical Products, Inc.1992-01-30
PROSPECT(TM) GIARDIA RAPID ASSAY (K915093)Alexon, Inc.1992-01-30
SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (K914022)Pharmacia Diagnostics, Inc.1992-01-27
ELISA TOXO IGM (K914852)Sclavo, Inc.1992-01-23
IMMUNOWELL LYME (P39 RECOMBINANT) TEST (K911599)General Biometrics, Inc.1991-12-30
ELISA RUBELLA IGM (K914420)Sclavo, Inc.1991-12-27
IMMUNOWELL BORRELIA (LYME)TEST (K911590)General Biometrics, Inc.1991-12-20
TOXOPLASMA IGM ELISA TEST SYSTEM (K913787)Zeus Scientific, Inc.1991-12-18
VIRAPURE, CHLAMYPURE AND MYCOPURE (K914894)Microtest1991-12-18
INFLUENZA MAB TEST/INFLUENZA A TEST (K913351)Gull Laboratories, Inc.1991-12-17
INFLUENZA MAB TEST/INFLUENZA B TEST (K913214)Gull Laboratories, Inc.1991-12-13
RSV-MAB TEST (K912842)Gull Laboratories, Inc.1991-12-09
CMV-EA MAB TEST (K912592)Gull Laboratories, Inc.1991-12-04
ABBOTT IMX TOXO IGM POSITIVE CONTROL (K913106)Abbott Laboratories1991-11-29
MARLOW SUCTION/IRRIGATION PROBES (K914872)Marlo Surgical Technology1991-11-19
WALKAWAY TM 40 (K911400)Baxter Healthcare Corp1991-11-19
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (K905608)Stellar Bio Systems, Inc.1991-11-07
LYME-CHECK(TM) TEST KIT (K896378)Diagnostic Technology, Inc.1991-11-05
OIA STREP A (K912889)Biosearch Medical Products, Inc.1991-10-31
SCEPTOR IDENTIFICATION SYSTEM (K912897)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-28
OPUS(R) ANTI CMV-M (K913080)Pb Diagnostics, Inc.1991-10-28
LYME STAT M TEST KIT (K904652)Whittaker Bioproducts, Inc.1991-10-21
PYLORISET (K904655)Orion Diagnostica, Inc.1991-10-21
BIOKIT RPR (K910541)Biokit USA, Inc.1991-10-18
FIAX LYME M TEST KIT (K904893)Whittaker Bioproducts, Inc.1991-10-16
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (K905211)Vitek Systems, Inc.1991-10-11
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST (K912255)Hycor Biomedical, Inc.1991-10-11
VISI-NEISSERIA (K913456)Kev Connecticut Diagnostics, Inc.1991-10-11
AEROBIC FOAM SWAB CULTURETTE(R) (K913789)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-09
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362)Amico Laboratories, Inc.1991-10-07
URI-THREE(TM), MODIFICATION (K911846)Culture Kits, Inc.1991-10-04
PYLORITRAK (K912215)Bainbridge Laboratories, Inc.1991-10-04
PROSPEC T/GIARDIA RAPID ASSAY (K911337)Alexon, Inc.1991-09-27
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838)Baxter Diagnostics, Inc.1991-09-27
THE E TEST, MODIFICATION (K913459)Ab Biodisk1991-09-25
EBNA STAT TEST KIT (K911473)Whittaker Bioproducts, Inc.1991-09-25
BACTIDROP(TM) VOGES-PROSKAUER B (K913007)Remel Co.1991-09-23
BACTIDROP(TM) FERRIC CHLORIDE (10%) (K913002)Remel Co.1991-09-23
BACTIDROP(TM) DOBELL & O'CONNOR IODINE (K913006)Remel Co.1991-09-23
BACTIDROP(TM) OXIDASE (K913008)Remel Co.1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER A (K913003)Remel Co.1991-09-23
BIOMERIEUX RSV DIRECT IF KIT (K912371)Vitek Systems, Inc.1991-09-23
QTEST INFLUENZA A (K913828)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-09-23
BACTIDROP(TM) NITRATE A (K913011)Remel Co.1991-09-19
BACTIDROP (TM) NITRATE B (K913010)Remel Co.1991-09-19
BACTIDROP(TM) INDOLE (KOVACS) (K913009)Remel Co.1991-09-18
BACTIDROP(TM) DESOXYCHOLATE (10%) (K913001)Remel Co.1991-09-18
BACTIDROP(TM) SPOT INDOLE (K913004)Remel Co.1991-09-18
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST (K912442)Quidel Corp.1991-09-16
GULL ELISAWARE (K912558)Gull Laboratories, Inc.1991-09-16
DIPSTICK SALMONELLA (K910438)Ampcor, Inc.1991-09-13
API UNISCEPT KB (K912965)Analytab Products, Inc.1991-09-06
CRYPTOSPORIDIUM ANTIGEN DETECTION (K905598)Lmd Laboratories1991-09-05
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (K911444)Wampole Laboratories1991-08-30
LYME-SPOT IF KIT (K910230)Vitek Systems, Inc.1991-08-30
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN (K913229)Baxter Diagnostics, Inc.1991-08-29
API UNISCEPT MIC/UNISCEPT MICRO-MIC (K912964)Analytab Products, Inc.1991-08-29
BBL(R) DMACA INDOLE REAGENT DROPPERS (K912480)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-08-23
GAP-IGG (K900343)Biomerica, Inc.1991-08-22
BACTI-SWAB(TM) NPG (K912832)Remel Co.1991-08-22
JUSTONE(TM) (K912846)Sensititre Microbiology A Div. of Radiometer1991-08-22
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) (K912613)Sensititre Microbiology A Div. of Radiometer1991-08-22
OPUS(R) ROZO (K911834)Pb Diagnostic Systems, Inc.1991-08-12
SLIDEX MENINGITE-KIT 5 (K910210)Vitek Systems, Inc.1991-08-12
CELLABS GIARDIA CEL I.F. TEST (K912152)Celltech Diagnostics , Ltd.1991-08-12
IDEIA(TM) CHLAMYDIA, MODIFICATION (K911430)Novo Nordisk Diagnostics, Ltd.1991-08-07
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS (K912868)Quidel Corp.1991-08-07
CYTOCLONE A & B EIA (K911958)Cambridge Biotech Corp.1991-07-30
BACTI-SWAB(TM) II (K912831)Remel Co.1991-07-30
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304)Vitek Systems, Inc.1991-07-26
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912489)Immuno Concepts, Inc.1991-07-24
ICON STREP B IMMUNOENZYMETRIC ASSAY (K911417)Hybritech, Inc.1991-07-24
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA (K912408)Meridian Diagnostics, Inc.1991-07-24
CROMATEST SYPHILIS DIAGNOSTIC (K904496)Biotrax, Inc.1991-07-24
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912488)Immuno Concepts, Inc.1991-07-24
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (K911640)Olympus Corp.1991-07-24
ANTIGENZ CHLAMYDIA (K912680)Baxter Diagnostics, Inc.1991-07-22
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150)Beckman Instruments, Inc.1991-07-17
VZV IGM TEST (K911301)Gull Laboratories, Inc.1991-07-17
ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (K911771)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-07-01
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (K904499)Ackrad Laboratories1991-07-01
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII (K905504)Dako Corp.1991-06-28
LYME DISEASE IGM ELISA (K900206)Hillcrest Biologicals1991-06-28
CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416)Biotrax, Inc.1991-06-24
COLOR VUE TM- MYCOPLASMA PNEUMONIAE (K910833)Seradyn, Inc.1991-06-24
FASTTECH SYSTEM 1 (K911496)3M Diagnostic Systems, Inc.1991-06-24
VISUWELL SYPHILIS ANTIGEN (K910487)Adi Diagnostics, Inc.1991-06-24
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429)Vitek Systems, Inc.1991-06-24
LYME IGM ELISA TEST (K903013)Gull Laboratories, Inc.1991-06-21
QM300 CALIBRATOR G PACK (K910885)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (K910886)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905306)Virion (U.S.), Inc.1991-06-17
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345)Diagnostic Hybrids, Inc.1991-06-17
QM300 CONTROL G PACK (K910887)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
VZVSCAN(TM) LATEX AGGUTINATION TEST (K912239)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-06-11
LYME IGM MICROASSAY (K911330)Diamedix Corp.1991-06-10
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