LRH

Product Code: LRH

Products Classified as LRH

3445

Instrument For Auto Reader Of Overnight Microorganism Identification System

Microorganism Differentiation And Identification Device.

Total Product Life Cycle (TPLC) Devices

3445

Instrument For Auto Reader Of Overnight Microorganism Identification System

Microorganism Differentiation And Identification Device.

FDA Consensus Standards

• Instrument For Auto Reader Of Overnight Microorganism Identification System [30236]: 21 CFR §866.2660 🔎
• Instrument For Auto Reader Of Overnight Microorganism Identification System [25388]: 21 CFR §866.2660 🔎

Pre-market Notifications for LRH

K962609	GRAM NEGATIVE IDENTIFICATION PLUS CARD	BIOMERIEUX VITEK, INC.
K961042	MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL	DADE MICROSCAN, INC.
K926248	READER	ALAMAR BIOSCIENCES LABORATORY, INC.

Global Unique Device Identification Database

• 00382904410100: INSTRUMENT FOR AUTO READER OF OVERNIGHT MICROORGANISM IDENTIFICATION SYSTEM

Maude Adverse Events

VITEK? 2 GRAM-NEGATIVE (GN) ID TEST KIT	BIOM?RIEUX, INC.	2016-11-15
VITEK? 2 GRAM NEGATIVE ID TEST KIT	BIOMERIEUX, INC	2016-09-30
VITEK? 2 GRAM NEGATIVE ID TEST KIT	BIOMERIEUX, INC	2016-09-30
VITEK? 2 GRAM NEGATIVE ID TEST KIT	BIOMERIEUX, INC	2016-08-08
VITEK? 2 GRAM NEGATIVE ID TEST KIT	BIOMERIEUX, INC	2016-08-05
VITEK? 2 GRAM NEGATIVE ID TEST KIT	BIOMERIEUX, INC	2016-08-04
OMNIQUEST	METROLOGIC INSTRUMENTS, INC.	2010-08-18
HNID PANEL	DADE BEHRING INC.	2005-05-23
HHP HAND-HELD BAR CODE SCANNER	HAND-HELD PRODUCTS, INC. S, INC.	2005-03-07
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2005-03-07
HHP HAND-HELD BAR CODE SCANNER	HAND HELD PRODUCTS, INC.	2005-02-14
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2005-02-14
HHP HAND HELD BAR CODE SCANNER	HAND HELD PRODUCTS INC	2004-12-27
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2004-12-27
HHP SCANNER	*	2004-12-21
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2004-12-21
HHP SCANNER	*	2004-12-21
INTERMEC BARCODE READER	ORTHO-CLINICAL DIAGNOSTICS	2003-11-24
**	*	2003-11-24
AUTO READER II	ORTHO-CLINICAL DIAGNOSTICS	2003-04-01
		2003-04-01
INTERMEC BARCODE WAND	ORTHO-CLINICAL DIAGNOSTICS	2003-03-03
AUTOREADER II	ORTHO-CLINICAL DIAGNOSTICS	2002-12-23
		2002-12-23
AUTOREADER II	ORTHO-CLINICAL DIAGNOSTICS	2002-11-05
**	*	2002-11-05
ORTHO ELISA BAR CODE READER II	INTERNEC CORPORATION	2002-03-27
ORTHO ELISA BARCODE READER II	ORTHO-CLINICAL DIAGNOSTICS	2002-03-12
		2002-03-12
ORTHO ELISA BAR CODE READER II	INTERMEC CORPORATION	2002-01-31
		2002-01-31
HNID PANEL	DADE MICROSCAN, INC.	2001-06-22
ORTHO ELISA BAR CODE READER II	INTERMEC TECHNOLOGY CORP.	2001-05-14
		2001-05-14
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	2001-05-08
ORTHO ELISA BAR CODE READER II	INTERMEC CORP.	2001-04-25
		2001-04-25
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	2000-12-20
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	2000-11-01
		2000-11-01
ORTHO ELISA BAR CODE READER II	INTERMEC CORP./GREENBROOK CORPORATE CENTER	2000-05-24
		2000-05-24
ORTHO ELISA BAR CODE READER II	INTERMEC CORP./GREENBROOK CORPORATE CENTER	2000-05-24
*		2000-05-16
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	2000-03-31
		2000-03-31
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	1999-11-09
		1999-11-09
ORTHO ELISA BAR CODE READER II	INTERMEC CORP	1999-11-02
		1999-11-02