Ammonia Standard R85406

Trade name

Ammonia Standard

Generic name

Ammonia IVD, control

Model / reference

R85406

Primary DI / UDI-DI

00817238011247

FDA product code

JIF

GMDN term

Ammonia IVD, control

Device class

Class I

Regulation number

862.1065

GUDID distribution status

In Commercial Distribution

Category: Ammonia IVD, control

Other devices filed under FDA product code JIF (Enzymatic Method, Ammonia).

• AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM by Bayer Diagnostics Corp.
• SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT by Beckman Coulter, Inc.
• PARAMAX AMMONIA AND AMMONIA BLANK REAGENT by Dade Intl., Inc.
• ABBOTT SPECTRUM AMMONIA REAGENT by Abbott Laboratories
• Dimension® Flex® reagent cartridge AMM 10711991 DF119 by Siemens Healthcare Diagnostics Inc.
• Atellica CH Amm 11097529 by Siemens Healthcare Diagnostics Inc.
• Ammonia II by Roche Diagnostics Operations, Inc.
• AMM by Abbott Laboratories
• AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 by Diagnostic Chemicals, Ltd.
• TEST, AMMONIA, BMC REAGENTSET by Boehringer Mannheim Corp.

• Whole Bld Volatiles Control Level 1 93221

  Class I

  FDA 510(k) K955691 Active Cleared 24 Apr 1996 GUDID on market

• ImmuTROL Serum Protein Contrl Level 3 91103

  Class I

  GUDID on market

• LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F 98501

  Class I

  FDA 510(k) K031575 Active Cleared 23 Jul 2003 GUDID on market

• Tumor Marker Control level 2 91302

  Class I

  FDA 510(k) K030705 Active Cleared 26 Mar 2003 GUDID on market

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