Drew Scientific DREW3-PAC

Trade name

Drew Scientific

Generic name

Medical device-decontamination agent

Model / reference

DREW3-PAC

Primary DI / UDI-DI

00817274020265

FDA product code

GGK

GMDN term

Medical device-decontamination agent

Device class

Class I

Regulation number

864.8540

GUDID distribution status

In Commercial Distribution

Category: Medical device-decontamination agent

Other devices filed under FDA product code GGK (Products, Red-Cell Lysing Products).

• THROMBO PLUS by W. Sarstedt, Inc.
• CYMET-AUTOMATED by J.T. Baker Chemical Co.
• IDL-LYSING REAGENT by Interscience Diagnostics, Inc.
• LYSING REAGENT by Omega Medical Diagnostics
• HEMOLYSE by Electrophoresis Corp. of America
• FISHER DIAGNOSTICS HEMATALL III LAS REAGENT by Fisher Scientific Co., LLC
• ACETIC ACID 2% V/V by E K Ind., Inc.
• CDL AUTO-LYSING REAGENT by Connecticut Diagnostics, Ltd.
• SERA-PAK TOTAL PROTEIN REAGENT by Miles Laboratories, Inc.
• REAGENT, LYSING AND HEMOGLOBIN by Dade, Baxter Travenol Diagnostics, Inc.

• JAS Diagnostics GLO2-BUP

  Class II

  FDA 510(k) K970781 Active Cleared 21 Apr 1997 GUDID on market

• JAS Diagnostics MICS-10

  Class II

  FDA 510(k) K070757 Active Cleared 4 Dec 2007 GUDID on market

• JAS Diagnostics TPT2-1L

  Class II

  GUDID on market

• Drew Scientific Pink Kit Hemolyzer (440mL)

  Class I

  GUDID on market

See all devices from Drew Scientific, Ltd. →