Product code LLH— Microbiology

FDA has cleared 42 devices under product code LLH between 1985 and 2021, filed by 22 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20211 clearance
• 20101 clearance
• 20093 clearances
• 20082 clearances
• 20071 clearance
• 20051 clearance
• 20044 clearances
• 20033 clearances
• 20001 clearance
• 19993 clearances
• 19981 clearance
• 19973 clearances
• 19961 clearance
• 19942 clearances
• 19935 clearances

• Techlab, Inc.11 clearances
• Meridian Diagnostics, Inc.6 clearances
• Marion Laboratories, Inc.3 clearances
• Remel, Inc.2 clearances
• bioMerieux, Inc.2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Vitek Systems, Inc.1 clearance
• Prodesse, Inc.1 clearance
• Meridian Bioscience, Inc.1 clearance
• Ivd Research, Inc.1 clearance

• K193490 — SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.·2021-07-08
• K102242 — OSOM C. DIFFICILE TOXIN A/B TESTGenzyme Corporation·2010-12-21
• K091109 — XPERT C. DIFFICILECepheid·2009-07-09
• K090239 — PROGASTRO CD ASSAYProdesse, Inc.·2009-04-16
• K082499 — C. DIFF QUIK CHEK COMPLETETechlab, Inc.·2009-03-26
• K081920 — BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)·2008-12-19
• K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, Inc.·2008-06-11
• K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118bioMerieux, Inc.·2007-12-21
• K050891 — TOX A/B QUICK CHEKTechlab, Inc.·2005-07-25
• K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BRemel, Inc.·2004-11-15
• K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050Meridian Bioscience, Inc.·2004-08-20
• K032897 — C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96Ivd Research, Inc.·2004-05-27
• K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYRemel, Inc.·2004-02-26
• K030991 — C. DIFF CHEK - 30Techlab, Inc.·2003-07-11
• K030992 — C. DIFF CHEK - 60Techlab, Inc.·2003-07-11
• K030404 — C. DIFFICILE TOX A/B IITechlab, Inc.·2003-04-24
• K003306 — C. DIFFICILE TOX A/B IITechlab, Inc.·2000-11-22
• K993914 — PREMIER TOXINS A&B, MODEL 616096Meridian Diagnostics, Inc.·1999-12-10
• K991829 — CDTOX A OIABiostar, Inc.·1999-11-02
• K990664 — PRIMA SYSTEM - OLD, BARTELS ELISA - NEWIntracel Corp.·1999-03-31
• K980185 — COLORPAC TOXIN ABd Becton Dickinson Vacutainer Systems Preanalytic·1998-07-17
• K971182 — TOX A/B TESTTechlab, Inc.·1997-07-22
• K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAYBiomerieux Vitek, Inc.·1997-04-08
• K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAYAlexon Biomedical, Inc.·1997-02-04
• K955859 — IMMUNOCARD TOXIN AMeridian Diagnostics, Inc.·1996-04-18
• K934493 — PROSPECT MICROPLATE ASSAYAlexon, Inc.·1994-09-20
• K935296 — CLOSTRIDIUM DIFFICILE TOX-B TESTTechlab, Inc.·1994-04-26
• K931129 — TECHLAB 1-HOUR TOX-A-TESTTechlab, Inc.·1993-09-30
• K925329 — CULTURETTE BRAND TOXIN CD TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1993-03-24
• K923463 — CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KITTechlab, Inc.·1993-02-01
• K926442 — PREMIER C. DIFFICILE, MODIFICATIONMeridian Diagnostics, Inc.·1993-01-27
• K924979 — IMMUNOCARD(TM) C. DIFFICILEMeridian Diagnostics, Inc.·1993-01-26
• K924136 — PREMIER C. DIFFICILE TOXIN A CONTROLSMeridian Diagnostics, Inc.·1992-10-19
• K914902 — CLOSTRIDIUM DIFFICILE TOX-A-TESTTechlab, Inc.·1992-03-04
• K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYVitek Systems, Inc.·1991-10-11
• K913229 — BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUNBaxter Diagnostics, Inc.·1991-08-29
• K911958 — CYTOCLONE A & B EIACambridge Biotech Corp.·1991-07-30
• K903456 — PREMIER-C. DIFFICILE TOXIN AMeridian Diagnostics, Inc.·1990-10-01
• K883560 — CDT CYTOTOXI TESTAdvanced Clinical Diagnostics·1988-10-25
• K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TESTMarion Laboratories, Inc.·1987-04-14
• K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TESTMarion Laboratories, Inc.·1986-09-17
• K852044 — CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXIMarion Laboratories, Inc.·1985-07-19