V Agar

510(k) Number

K844513 ↗

FDA product code

JSH

Device class

Class I

Regulation

21 CFR Part 866.2320

Advisory committee

Microbiology

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code JSH (Culture Media, Non-Selective And Differential).

• DRI-FORM PSEUDOMONAS AGAR F by Gibco Laboratories Life Technologies, Inc.
• LOMBARD-DOWELL MILK AGAR by Anaerobe Systems
• SIM MEDIUM by Acumedia Manufacturers, Inc.
• SIMMONS CITRATE AGAR by Preferred Micro-Media
• BTB LACTOSE AGAR by Acumedia Manufacturers, Inc.
• OXIDATIVE FORMENTIVE MEDIUM by Micro Media Laboratories
• APL DNASE TEST AGAR by Apl Medical Supplies
• BIRD SEED AGAR by Bd Becton Dickinson Vacutainer Systems Preanalytic
• APL BILE ESCULIN/AZIDE AGAR by Apl Medical Supplies
• #50003 QUAD DIAGNOSTIC SYSTEM by Biomedia, Inc.

• VITEK REVEAL SOFTWARE v1.3 CONTROL

  Class II

  CE/IVDR FDA 510(k) ×2 Active Cleared 20 Jun 2024 +1authorizations

• Vitek® 2 Ast-N816 Open recall

  Class II

  FDA 510(k) ×5 Active Cleared 19 Dec 2017 GUDID on market

• Columbia Sheep Blood Agar 5%

  Class I

  FDA 510(k) K830075 Active Cleared 9 Feb 1983

• Brain Heart Infusion Broth

  Class I

  FDA 510(k) K844529 Active Cleared 7 Jan 1985

See all devices from Biomerieux, Inc. →