Diagnostic Hybrids, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K092229	THYRETAIN TM TSI REPORTER BIOASSAY	JZO	2010-05-18	View
510(k)	K093415	D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT	GQS	2009-12-23	View
510(k)	K093233	D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT	OMG	2009-12-04	View
510(k)	K092882	D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT	GNW	2009-10-21	View
510(k)	K091171	D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT	OMG	2009-09-11	View
510(k)	K092300	MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT	GNW	2009-08-28	View
510(k)	K091753	ELVIS HSV ID AND D3 TYPING TEST SYSTEM	GQL	2009-08-28	View
510(k)	K083391	THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY	JZO	2009-05-21	View
510(k)	K090073	D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT	OMG	2009-03-06	View
510(k)	K081746	D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT	GNW	2008-12-23	View
510(k)	K081928	D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT	LKT	2008-12-23	View
510(k)	K081164	D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT	LIN	2008-06-13	View
510(k)	K070265	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000	GQN	2007-10-24	View
510(k)	K063675	DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT	LJP	2007-09-24	View
510(k)	K063798	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000	GQN	2007-09-21	View
510(k)	K070206	DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000	GQW	2007-08-30	View
510(k)	K061101	D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT	GNW	2006-11-20	View
510(k)	K022713	DFA RESPIRATORY VIRUS SCREENING & ID KIT	GNW	2002-12-18	View
510(k)	K971662	ELVIS HSV ID/TYPING TEST SYSTEM	GQN	1997-11-18	View
510(k)	K973214	FRESH CELLS HFF	KIR	1997-09-25	View