Company ยท US
Diagnostic Hybrids, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2014. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 14 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 7 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 5 |
| OMG | Antisera, Fluorescent, Human Metapneumovirus | 3 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 |
| JZH | Factor B, Antigen, Antiserum, Control | 1 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
| N/A | 1 | |
| OTR | Research Use Only/Immunology Devices | 1 |
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 13, 2014 | DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY Diagnostic Hybrids, Inc. | PGI |
| May 18, 2010 | K092229 | THYRETAIN TM TSI REPORTER BIOASSAY Diagnostic Hybrids, Inc. | JZO |
| Dec 23, 2009 | K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT Diagnostic Hybrids, Inc. | GQS |
| Dec 4, 2009 | K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT Diagnostic Hybrids, Inc. | OMG |
| Oct 21, 2009 | K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT Diagnostic Hybrids, Inc. | GNW |
| Sep 11, 2009 | K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT Diagnostic Hybrids, Inc. | OMG |
| Aug 28, 2009 | K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Aug 28, 2009 | K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM Diagnostic Hybrids, Inc. | GQL |
| May 21, 2009 | K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY Diagnostic Hybrids, Inc. | JZO |
| Mar 6, 2009 | K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT Diagnostic Hybrids, Inc. | OMG |
| Dec 23, 2008 | K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT Diagnostic Hybrids, Inc. | LKT |
| Dec 23, 2008 | K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT Diagnostic Hybrids, Inc. | GNW |
| Jun 13, 2008 | K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT Diagnostic Hybrids, Inc. | LIN |
| Oct 24, 2007 | K070265 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 Diagnostic Hybrids, Inc. | GQN |
| Sep 24, 2007 | K063675 | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT Diagnostic Hybrids, Inc. | LJP |
| Sep 21, 2007 | K063798 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 Diagnostic Hybrids, Inc. | GQN |
| Aug 30, 2007 | K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 Diagnostic Hybrids, Inc. | GQW |
| Nov 20, 2006 | K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Dec 18, 2002 | K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Nov 18, 1997 | K971662 | ELVIS HSV ID/TYPING TEST SYSTEM Diagnostic Hybrids, Inc. | GQN |
| Sep 25, 1997 | K973214 | FRESH CELLS HFF Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973213 | FRESH CELLS LLC-MK2 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973212 | FRESH CELLS WI-38 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973211 | FRESH CELLS MV1LU Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973210 | FRESH CELLS NCI H292 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973209 | FRESH CELLS VERO Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1997 | K972414 | FRESHCELLS Diagnostic Hybrids, Inc. | KIR |
| Sep 5, 1996 | K960578 | ELVIS HSV GOLD Diagnostic Hybrids, Inc. | GQN |
| Aug 29, 1996 | K962782 | FRESHFROZEN CELLS, HEP-2 Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962780 | FRESHCELLS, HEP-2 Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962311 | FRESHFROZENCELLS Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962306 | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES Diagnostic Hybrids, Inc. | KIR |
| May 1, 1995 | K941924 | ELVIS HSV Diagnostic Hybrids, Inc. | GQN |
| Aug 26, 1994 | K936271 | FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE Diagnostic Hybrids, Inc. | KIR |
| Jun 16, 1994 | K940502 | FRESH FROZEN CELLS Diagnostic Hybrids, Inc. | KIR |
| Jun 17, 1991 | K911345 | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT Diagnostic Hybrids, Inc. | GQN |
| Aug 25, 1988 | K873529 | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT Diagnostic Hybrids, Inc. | GQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Diagnostic Hybrids, Inc. MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma.
The assay uses highly pure, functional human C1q coated in the soli Terminated |
DAK | K862649 |
| Oct 26, 2016 | Diagnostic Hybrids, Inc. Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. Terminated |
CEW | K974306 |
| Jul 14, 2016 | Diagnostic Hybrids, Inc. MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. Terminated |
CIN | K981373 |
| Nov 3, 2015 | Diagnostic Hybrids, Inc. MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum. Terminated |
N/A | None listed |
| Nov 3, 2015 | Diagnostic Hybrids, Inc. MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum. Terminated |
OTR | None listed |
| Nov 3, 2015 | Diagnostic Hybrids, Inc. MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma.
The MicroVue CIC-C1q EIA is for detection of circulating im Terminated |
DAK | K862649 |
| Sep 3, 2015 | Diagnostic Hybrids Inc MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic. Terminated |
JZH | None listed |
| Feb 7, 2013 | Diagnostic Hybrids Inc Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, mea Terminated |
LKA | None listed |
| Feb 24, 2010 | Diagnostic Hybrids Inc Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product i Terminated |
KIR | None listed |