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Microbiology

3,049 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
DIASORIN ETI-EBK PLUS (P990043/S003)DiaSorin, Inc.2002-11-08
DIASORIN ETI-CORE-IGMK PLUS (P990044/S002)DiaSorin, Inc.2002-11-08
DIASORIN ETI-AB-EBK PLUS (P990041/S002)DiaSorin, Inc.2002-11-08
VERSANT HCV RNA QUALITATIVE ASSAY (P020011)Gen-Probe2002-11-07
HAVAB-M EIA (P790019/S016)Abbott Laboratories2002-11-06
QUANTIFERON-TB (P010033/S001)Qiagen2002-10-24
ABBOTT HAVAB/HAVAB EIA/IMX HAVAB (P780012/S012)Abbott Laboratories2002-09-05
HAVAB-M (R) EIA (P790019/S012)Abbott Laboratories2002-09-05
IMX HAVAB-M (P790019/S015)Abbott Laboratories2002-09-05
ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263 (P790019/S014)Abbott Laboratories2002-09-05
HAVAB (R) EIA (P780012/S010)Abbott Laboratories2002-09-05
IMX HAVAB (P780012/S013)Abbott Laboratories2002-09-05
ABBOTT ANTI-DELTA (EIA) ASSAY (P850062/S003)Abbott Laboratories2002-09-05
ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M (P790019/S013)Abbott Laboratories2002-09-05
ABBOTT HAVAB/HAVAB EIA/IMX HAVAB (P780012/S011)Abbott Laboratories2002-09-05
IMMULITE 2000 XPI HBSAG (P010050)Siemens Healthcare Diagnostics Products, Ltd.2002-07-26
IMMULITE 2000 XPI ANTI-HBC IMG (P010053)Siemens Healthcare Diagnostics Products, Ltd.2002-07-26
IMMULITE 2000 XPI ANTI-HBC (P010051)Siemens Healthcare Diagnostics Products, Ltd.2002-07-24
IMMULITE 2000 XPI ANTI-HBS (P010052)Siemens Healthcare Diagnostics Products, Ltd.2002-07-22
DIASORIN ETI-AB-AUK PLUS ASSAY (P990042/S003)DiaSorin, Inc.2002-06-24
ETI-EBK PLUS (P990043/S002)DiaSorin, Inc.2002-03-11
ETI-AB-COREK PLUS (P990045/S002)DiaSorin, Inc.2002-03-07
DIASORIN ETI-AB-EBK PLUS (P990041/S001)DiaSorin, Inc.2002-03-07
ETI-MAK-2 PLUS (P990038/S002)DiaSorin, Inc.2002-03-07
ETI-CORE-IGMK PLUS (P990044/S001)DiaSorin, Inc.2002-03-06
ETI-AB-AUK PLUS (P990042/S002)DiaSorin, Inc.2002-03-05
ELECSYS ANTI-HBS (P010054)Roche Diagnostics Corp.2002-02-28
ETI-AB-AUK PLUS ASSAY (P990042/S001)DiaSorin, Inc.2002-02-04
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST) (P940034/S013)Gen-Probe, Inc.2002-01-25
MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032)Dade Intl., Inc.2001-11-30
QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE (P010033)Qiagen2001-11-28
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031)Dade Intl., Inc.2001-11-09
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146)Biomerieux Vitek, Inc.2001-10-17
COBAS AMPLICOR HCV TEST, V2.0 (P000012/S001)Roche Molecular Systems, Inc.2001-10-12
COBAS AMPLICOR HCV TEST, V2.0 (P000010/S001)Roche Molecular Systems, Inc.2001-10-12
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S012)Gen-Probe, Inc.2001-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021)Ortho-Clinical Diagnostics, Inc.2001-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S002)Ortho-Clinical Diagnostics, Inc.2001-08-29
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 (P000010)Roche Molecular Systems, Inc.2001-07-05
COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012)Roche Molecular Systems, Inc.2001-07-03
VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145)Biomerieux Vitek, Inc.2001-06-25
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT (P000044/S002)Ortho-Clinical Diagnostics, Inc.2001-06-18
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144)Biomerieux Vitek, Inc.2001-06-13
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012)Roche Diagnostics Corp.2001-06-01
VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142)Biomerieux Vitek, Inc.2001-05-30
VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT (P000044/S001)Ortho-Clinical Diagnostics, Inc.2001-05-24
VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141)Biomerieux Vitek, Inc.2001-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044)Ortho-Clinical Diagnostics, Inc.2001-04-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S004)Ortho-Clinical Diagnostics, Inc.2001-04-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S003)Ortho-Clinical Diagnostics, Inc.2001-04-19
DIASORIN ETI-AB-EBK PLUS ASSAY (P990041)DiaSorin, Inc.2001-03-30
DIASORIN ETI MAK-2 PLUS ASSAY (P990038)DiaSorin, Inc.2001-03-30
DIASORIN ETI-CORE-IGMK PLUS ASSAY (P990044)DiaSorin, Inc.2001-03-30
DIASORIN ETI-AB-COREK PLUS ASSAY (P990045)DiaSorin, Inc.2001-03-30
DIASORIN ETI-AB-AUK PLUS ASSAY (P990042)DiaSorin, Inc.2001-03-30
HOME ACCESS HEPATITIS C CHECK TEST (P980046/S004)Pwn Health Chicago, LLC2001-03-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S001)Ortho-Clinical Diagnostics, Inc.2001-03-20
VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140)Biomerieux Vitek, Inc.2001-03-09
DIASORIN ETI-EBK PLUS ASSAY (P990043)DiaSorin, Inc.2001-02-08
HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS (P890014/S003)DiaSorin, Inc.2001-02-02
EBK RIA ASSAY/ETI-EBK (P870048/S008)Diasorin2001-02-02
AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS (P890019/S006)Diasorin2001-02-02
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S011)Gen-Probe, Inc.2000-11-21
VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS (P000014)Ortho-Clinical Diagnostics, Inc.2000-09-29
ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S001)Roche Molecular Systems, Inc.2000-09-12
HCS HPV, HCII HPV (P890064/S008)Qiagen Gaithersburg, Inc.2000-09-12
VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138)Biomerieux Vitek, Inc.2000-08-11
VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S139)Biomerieux Vitek, Inc.2000-06-26
VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN (N50510/S137)Biomerieux Vitek, Inc.2000-06-21
VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE (N50510/S135)Biomerieux Vitek, Inc.2000-06-21
VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE (N50510/S136)Biomerieux Vitek, Inc.2000-06-21
VITEK 2 GRAM POSITIVE AST FOR ERYTHROMYCIN (N50510/S134)Biomerieux Vitek, Inc.2000-06-14
VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN (N50510/S133)Biomerieux Vitek, Inc.2000-06-09
VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL (N50510/S132)Biomerieux Vitek, Inc.2000-06-08
VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME (N50510/S131)Biomerieux Vitek, Inc.2000-06-06
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S030)Dade Intl., Inc.2000-06-05
VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME (N50510/S130)Biomerieux Vitek, Inc.2000-05-18
VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM (N50510/S129)Biomerieux Vitek, Inc.2000-04-26
VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID (N50510/S128)Biomerieux Vitek, Inc.2000-04-17
HEPATITIS C CHECK TESTING SERVICE (P980046/S002)Pwn Health Chicago, LLC2000-04-12
VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN (N50510/S127)Biomerieux Vitek, Inc.2000-04-05
VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM (N50510/S125)Biomerieux Vitek, Inc.2000-03-31
VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN (N50510/S126)Biomerieux Vitek, Inc.2000-03-31
VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME (N50510/S122)Biomerieux Vitek, Inc.2000-03-20
VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID (N50510/S123)Biomerieux Vitek, Inc.2000-03-20
VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID (N50510/S124)Biomerieux Vitek, Inc.2000-03-20
DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST (P890064/S007)Qiagen Gaithersburg, Inc.2000-03-16
VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM (N50510/S121)Biomerieux Vitek, Inc.2000-03-09
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM (N50510/S119)Biomerieux Vitek, Inc.2000-02-17
VITEK 2 GRAM POSITIVE AST FOR OXACILLIN (N50510/S117)Biomerieux Vitek, Inc.2000-02-15
VITEK 2 GRAM NEGATIVE AST FOR CEFOXITIN (N50510/S118)Biomerieux Vitek, Inc.2000-02-10
VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN (N50510/S116)Biomerieux Vitek, Inc.2000-02-08
VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN (N50510/S113)Biomerieux Vitek, Inc.2000-02-08
VITEK 2 GRAM NEGATIVE TETRACYCLINE (N50510/S115)Biomerieux Vitek, Inc.2000-02-08
VITEK 2 GRAM NEGATIVE NORFLOXACIN (N50510/S114)Biomerieux Vitek, Inc.2000-02-07
VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN (N50510/S112)Biomerieux Vitek, Inc.2000-02-01
VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME (N50510/S120)Biomerieux Vitek, Inc.2000-02-01
VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN (N50510/S110)Biomerieux Vitek, Inc.2000-01-31
VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN (N50510/S111)Biomerieux Vitek, Inc.2000-01-31
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