LLH

Product Code: LLH


Products Classified as LLH

3429Reagents, Clostridium Difficile ToxinMicroorganism Differentiation And Identification Device.

Total Product Life Cycle (TPLC) Devices

3429Reagents, Clostridium Difficile ToxinMicroorganism Differentiation And Identification Device.

FDA Consensus Standards

Reagents, Clostridium Difficile Toxin [33208]21 CFR §866.2660 🔎

Pre-market Notifications for LLH

K193490SensiTox C. Difficile Toxin TestFirst Light Diagnostics, Inc.
K102242OSOM C. DIFFICILE TOXIN A/B TESTGENZYME CORPORATION
K091109XPERT C. DIFFICILECEPHEID
K090239PROGASTRO CD ASSAYPRODESSE, INC.
K082499C. DIFF QUIK CHEK COMPLETETECHLAB, INC.
K081920BD GENEOHM CDIFF ASSAYBD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYBIOMERIEUX, INC.
K072138VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118BIOMERIEUX, INC.
K050891TOX A/B QUICK CHEKTECHLAB, INC.
K041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BREMEL INC
K041003IMMUNOCARD TOXINS A & B, MODEL 712050MERIDIAN BIOSCIENCE, INC.
K033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYREMEL INC
K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96IVD RESEARCH, INC.
K030992C. DIFF CHEK - 60TECHLAB, INC.
K030404C. DIFFICILE TOX A/B IITECHLAB, INC.

Global Unique Device Identification Database

00857031002424Reagents, Clostridium Difficile Toxin
00857031002387Reagents, Clostridium Difficile Toxin
00857031002370Reagents, Clostridium Difficile Toxin
00857031002257Reagents, Clostridium Difficile Toxin
00857031002233Reagents, Clostridium Difficile Toxin
00857031002158Reagents, Clostridium Difficile Toxin
00857031002103Reagents, Clostridium Difficile Toxin
00857031002059Reagents, Clostridium Difficile Toxin
00857031002042Reagents, Clostridium Difficile Toxin
07332940000059Reagents, Clostridium Difficile Toxin
07332940000035Reagents, Clostridium Difficile Toxin
05391516748780Reagents, Clostridium Difficile Toxin
05391516748773Reagents, Clostridium Difficile Toxin
15420045506350REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN
00857031002226Reagents, Clostridium Difficile Toxin

Maude Adverse Events

IMMUNOCARDMERIDIAN BIOSCIENCE, INC2010-11-24
CULTURETTE TOXIN CDBECTON DICKINSON1999-04-23
CLOSTRIDIUM DIFFICILE TOX-A-TESTBIOWHITTAKER, INC.1994-08-22

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