FDA 510(k) Applications Submitted by DIAGNOSTIC HYBRIDS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070206 |
01/22/2007 |
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 |
DIAGNOSTIC HYBRIDS, INC. |
| K070265 |
01/29/2007 |
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 |
DIAGNOSTIC HYBRIDS, INC. |
| K063675 |
12/11/2006 |
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K063798 |
12/22/2006 |
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 |
DIAGNOSTIC HYBRIDS, INC. |
| K090073 |
01/12/2009 |
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K061101 |
04/20/2006 |
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K081164 |
04/24/2008 |
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K081746 |
06/19/2008 |
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K081928 |
07/07/2008 |
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K083391 |
11/17/2008 |
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
| K973209 |
08/27/1997 |
FRESH CELLS VERO |
DIAGNOSTIC HYBRIDS, INC. |
| K973210 |
08/27/1997 |
FRESH CELLS NCI H292 |
DIAGNOSTIC HYBRIDS, INC. |
| K973211 |
08/27/1997 |
FRESH CELLS MV1LU |
DIAGNOSTIC HYBRIDS, INC. |
| K973212 |
08/27/1997 |
FRESH CELLS WI-38 |
DIAGNOSTIC HYBRIDS, INC. |
| K973213 |
08/27/1997 |
FRESH CELLS LLC-MK2 |
DIAGNOSTIC HYBRIDS, INC. |
| K973214 |
08/27/1997 |
FRESH CELLS HFF |
DIAGNOSTIC HYBRIDS, INC. |
| K960578 |
02/12/1996 |
ELVIS HSV GOLD |
DIAGNOSTIC HYBRIDS, INC. |
| K971662 |
04/29/1997 |
ELVIS HSV ID/TYPING TEST SYSTEM |
DIAGNOSTIC HYBRIDS, INC. |
| K962311 |
06/17/1996 |
FRESHFROZENCELLS |
DIAGNOSTIC HYBRIDS, INC. |
| K962306 |
06/17/1996 |
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES |
DIAGNOSTIC HYBRIDS, INC. |
| K972414 |
06/27/1997 |
FRESHCELLS |
DIAGNOSTIC HYBRIDS, INC. |
| K962780 |
07/17/1996 |
FRESHCELLS, HEP-2 |
DIAGNOSTIC HYBRIDS, INC. |
| K962782 |
07/17/1996 |
FRESHFROZEN CELLS, HEP-2 |
DIAGNOSTIC HYBRIDS, INC. |
| K022713 |
08/14/2002 |
DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
| DEN140004 |
02/21/2014 |
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
| K091171 |
04/22/2009 |
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K091753 |
06/16/2009 |
ELVIS HSV ID AND D3 TYPING TEST SYSTEM |
DIAGNOSTIC HYBRIDS, INC. |
| K092229 |
07/23/2009 |
THYRETAIN TM TSI REPORTER BIOASSAY |
DIAGNOSTIC HYBRIDS, INC. |
| K092300 |
07/29/2009 |
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K092882 |
09/18/2009 |
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K093233 |
10/14/2009 |
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
| K093415 |
11/02/2009 |
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
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