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Microbiology

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

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RecordFirmDate
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST (K854447)American Micro Scan1986-01-03
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST (K854081)Boots-Celltech Diagnostics, Inc.1986-01-03
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU (K854986)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-03
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT (K853069)Hybritech, Inc.1986-01-01
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (K854490)American Micro Scan1985-12-27
DIRECT ELISA FOR HERPES SIMPLEX VIRUS (K853307)Fairleigh Dickinson Laboratories, Inc.1985-12-23
BIOGRAM (K854521)Giles Scientific, Inc.1985-12-23
TRANSPORT CULTURE MEDIA (K854715)Hillcrest Biologicals1985-12-23
ANTI-EPSTEIN-BARR VIRUS KIT (K842662)Amico Lab, Inc.1985-12-12
AUTO MASH (K854604)Dynatech Corp.1985-12-06
AMIZYME-HSV TYPES 1 & 2 TEST KITS (K842531)Amico Lab, Inc.1985-12-06
ANTI-CYTOMEGALOVIRUS KIT (K842661)Amico Lab, Inc.1985-12-06
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST (K853738)Ortho Diagnostic Systems, Inc.1985-12-06
MULTI MASH 2000 (K854603)Dynatech Corp.1985-12-06
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (K842663)Amico Lab, Inc.1985-12-06
AMIZYME-CMV KIT (K842529)Amico Lab, Inc.1985-12-06
MINI MASH 2000 (K854602)Dynatech Corp.1985-12-06
AMIZYME-EBV TEST KIT (K842530)Amico Lab, Inc.1985-12-06
ABBOTT STREP A P.S.D. (K852266)Abbott Laboratories1985-12-05
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT (K853695)Viromed Laboratories, Inc.1985-12-04
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (K842830)Bartels Immunodiagnostic Supplies, Inc.1985-11-26
AUTOSCAN W/A SYSTEM (K854448)American Micro Scan1985-11-26
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS (K853554)Kallestad Laboratories, Inc.1985-11-26
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES (K854423)Dynatech Laboratories, Inc.1985-11-20
CDC ANAEROBE BLOOD AGAR (K854455)R. Kent Richards, Inc.1985-11-18
COLUMBIA CNA AGAR W/5% SHEEP BLOOD (K854457)R. Kent Richards, Inc.1985-11-18
TRYPTIC SOY BLOOD AGAR (K854454)R. Kent Richards, Inc.1985-11-18
P.E.Z. AGAR (PHENYLETHANOL AGAR) (K854453)R. Kent Richards, Inc.1985-11-18
HEKTOEN ENTERIC AGAR (K854449)R. Kent Richards, Inc.1985-11-18
CAMPYLOBACTER BLOOD AGAR (K854456)R. Kent Richards, Inc.1985-11-18
MANNITOL SALT AGAR (K854452)R. Kent Richards, Inc.1985-11-18
BILE ESCULIN AZIDE AGAR (K854450)R. Kent Richards, Inc.1985-11-18
MUELLER HINTON MEDIUM (K854451)R. Kent Richards, Inc.1985-11-18
SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL (K854099)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL (K854097)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR GRAM POSITIVE MIC/ID PANEL (K854100)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR GRAM POSITIVE MIC PANEL (K854101)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR PSEUDOMONAS PLUS MIC PANEL (K854098)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR ENTERIC MIC PANEL (K854102)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
CMV TEST (K853137)Gull Laboratories, Inc.1985-11-14
SCEPTOR ENTERIC MIC/ID PANEL (K854103)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
THAYER-MARTIN MEDIUM (MOD) (K854275)R. Kent Richards, Inc.1985-11-12
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (K852929)Microbix Biosystems, Inc.1985-11-12
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO (K854108)Medical Diagnostic Technologies, Inc.1985-11-12
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (K852931)Microbix Biosystems, Inc.1985-11-12
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (K852932)Microbix Biosystems, Inc.1985-11-12
VIROGEN ROTATEST SLIDE TEST (K853399)Armkel, LLC1985-11-12
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (K852930)Microbix Biosystems, Inc.1985-11-12
MEBIASIS AGAR GEL DIFFUSION KIT (K854230)Lmd Laboratories1985-11-12
ECHO TYPE 16 CF ANTIGEN (K853156)Hillcrest Biologicals1985-11-07
ECHO TYPE 30 CF ANTIGEN (K853165)Hillcrest Biologicals1985-11-07
COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 (K853279)Hillcrest Biologicals1985-11-07
POLIO TYPE I CF ANTIGEN, & TYPE II, III (K853278)Hillcrest Biologicals1985-11-07
CMV CF ANTIGEN (K853277)Hillcrest Biologicals1985-11-07
ECHO TYPE 11 CF ANTIGEN (K853157)Hillcrest Biologicals1985-11-07
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (K852969)Cambridge Bioscience Corp.1985-11-05
ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245)Behring Diagnostics, Inc.1985-11-05
COLUMBIA 5% BLOOD AGAR (K854228)R. Kent Richards, Inc.1985-10-31
LASER ASO KIT (K854039)Behring Diagnostics, Inc.1985-10-28
PHADIRECT STREP A TEST (K854150)Pharmacia, Inc.1985-10-23
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR (K854064)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-23
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM (K854061)Syva Co.1985-10-23
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067)Idt, A Division of Whittaker M.A. Bioproducts1985-10-22
ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (K854017)Lmd Laboratories1985-10-22
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER (K853920)Bio-Tek Instruments, Inc.1985-10-22
PHADEBACT CSF TEST (K844999)Pharmacia, Inc.1985-10-17
VIROGEN HERPES SLIDE TEST (K852928)Armkel, LLC1985-10-17
HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (K851977)Si Sero-Immuno Diagnostics, Inc.1985-10-16
V-TREND ASO PLUS LATEX TEST (K853857)Texas Immunology, Inc.1985-10-16
HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (K851976)Si Sero-Immuno Diagnostics, Inc.1985-10-16
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST (K851635)Diagnon Corp.1985-10-10
MYWASHER 5 (K853285)Scientific Sales Intl., Inc.1985-10-04
PARA CON TM (K853715)Para Scientific Co.1985-10-02
INFLUENZA A2 VIRUS (K843659)Institute Virion , Ltd.1985-09-26
PARAINFLUENZA 1 (K843665)Institute Virion , Ltd.1985-09-26
RESPIRATORY SYNCYTIAL VIRUS (K843673)Institute Virion , Ltd.1985-09-26
CYTOMEGALOVIRUS (K843657)Institute Virion , Ltd.1985-09-26
VARICELLA/ZOSTER VIRUS (K843676)Institute Virion , Ltd.1985-09-26
PARAINFLUENZA 3 (K843667)Institute Virion , Ltd.1985-09-26
IN FLUENZA B VIRUS (K843660)Institute Virion , Ltd.1985-09-26
ADENOVIRUS (K843649)Institute Virion , Ltd.1985-09-26
H. SIMPLEX VIRUS (K843658)Institute Virion , Ltd.1985-09-26
MEASLES VIRUS RUBEOLA (K843662)Institute Virion , Ltd.1985-09-26
MIC-CONCEPT SYSTEM (K852613)Microtech Medical Systems, Inc.1985-09-20
SELECTICULT-CHLAMYDIA (K852869)Scott Laboratories, Inc.1985-09-19
MIC-CONCEPT VIEWBOX (K853745)Microtech Medical Systems, Inc.1985-09-19
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (K853122)Immuno-Products Industries1985-09-19
TERGITOL 7 AGAR (K853691)Micro Media Laboratories1985-09-17
ABBOTT RSV EIA (K852472)Abbott Laboratories1985-09-17
COLUMBIZ BLOOD AGAR (K853690)Micro Media Laboratories1985-09-17
PRECEPT CEFOPERAZONE (K853596)Austin Biological Laboratories1985-09-16
ENZYGNOST + ANTI-CMV IGG TEST (K852478)Behring Diagnostics, Inc.1985-09-16
CMV-IHA (K852494)Hillcrest Biologicals1985-09-16
PRECEPT CEFTRIAXONE (K853273)Austin Biological Laboratories1985-09-16
APL SIMMONS CITRATE AGAR (K853617)Apl Medical Supplies1985-09-16
APL SIM MEDIUM (K853618)Apl Medical Supplies1985-09-16
PRECEPT TM CARBENICILLIN (K853685)Austin Biological Laboratories1985-09-16
APL MOTILITY INDOLE ORNITHINE AGAR (K853610)Apl Medical Supplies1985-09-16
APL TRIPLE SUGAR IRON AGAR (K853619)Apl Medical Supplies1985-09-16
PRECEPT METHICILLIN (K853772)Austin Biological Laboratories1985-09-16
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