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Diagnostic Hybrids, Inc.

37 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (DEN140004)Diagnostic Hybrids, Inc.2014-05-13
THYRETAIN TM TSI REPORTER BIOASSAY (K092229)Diagnostic Hybrids, Inc.2010-05-18
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415)Diagnostic Hybrids, Inc.2009-12-23
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233)Diagnostic Hybrids, Inc.2009-12-04
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882)Diagnostic Hybrids, Inc.2009-10-21
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (K091171)Diagnostic Hybrids, Inc.2009-09-11
ELVIS HSV ID AND D3 TYPING TEST SYSTEM (K091753)Diagnostic Hybrids, Inc.2009-08-28
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300)Diagnostic Hybrids, Inc.2009-08-28
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (K083391)Diagnostic Hybrids, Inc.2009-05-21
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073)Diagnostic Hybrids, Inc.2009-03-06
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928)Diagnostic Hybrids, Inc.2008-12-23
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746)Diagnostic Hybrids, Inc.2008-12-23
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (K081164)Diagnostic Hybrids, Inc.2008-06-13
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 (K070265)Diagnostic Hybrids, Inc.2007-10-24
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675)Diagnostic Hybrids, Inc.2007-09-24
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798)Diagnostic Hybrids, Inc.2007-09-21
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (K070206)Diagnostic Hybrids, Inc.2007-08-30
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101)Diagnostic Hybrids, Inc.2006-11-20
DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713)Diagnostic Hybrids, Inc.2002-12-18
ELVIS HSV ID/TYPING TEST SYSTEM (K971662)Diagnostic Hybrids, Inc.1997-11-18
FRESH CELLS WI-38 (K973212)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS MV1LU (K973211)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS NCI H292 (K973210)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS VERO (K973209)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS HFF (K973214)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS LLC-MK2 (K973213)Diagnostic Hybrids, Inc.1997-09-25
FRESHCELLS (K972414)Diagnostic Hybrids, Inc.1997-08-29
ELVIS HSV GOLD (K960578)Diagnostic Hybrids, Inc.1996-09-05
FRESHFROZENCELLS (K962311)Diagnostic Hybrids, Inc.1996-08-29
FRESHFROZEN CELLS, HEP-2 (K962782)Diagnostic Hybrids, Inc.1996-08-29
FRESHCELLS, HEP-2 (K962780)Diagnostic Hybrids, Inc.1996-08-29
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306)Diagnostic Hybrids, Inc.1996-08-29
ELVIS HSV (K941924)Diagnostic Hybrids, Inc.1995-05-01
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (K936271)Diagnostic Hybrids, Inc.1994-08-26
FRESH FROZEN CELLS (K940502)Diagnostic Hybrids, Inc.1994-06-16
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345)Diagnostic Hybrids, Inc.1991-06-17
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529)Diagnostic Hybrids, Inc.1988-08-25

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Every clearance here is in the API, with alerts when new ones post.