Diagnostic Hybrids, Inc.
Diagnostic Hybrids, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2014, with 8 FDA device recalls on record.
Top product codes for Diagnostic Hybrids, Inc.
FDA recalls by Diagnostic Hybrids, Inc.
- Z-1496-2018 — 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 solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
- Z-1520-2018 — Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
- Z-1797-2018 — MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
- Z-1499-2018 — 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.
- Z-1498-2018 — 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.
- Z-1497-2018 — 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 immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
- Z-0417-2015 — MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
- Z-0792-2013 — 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, measles, and poliovirus from patient specimens.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Diagnostic Hybrids, Inc.
- DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
- K092229 — THYRETAIN TM TSI REPORTER BIOASSAY
- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
- K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
- K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM
- K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
- K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
- K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
- K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
- K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
- K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
- K063675 — DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
- K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
- K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- K061101 — D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K022713 — DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K971662 — ELVIS HSV ID/TYPING TEST SYSTEM
- K973209 — FRESH CELLS VERO
- K973210 — FRESH CELLS NCI H292
- K973211 — FRESH CELLS MV1LU
- K973212 — FRESH CELLS WI-38
- K973213 — FRESH CELLS LLC-MK2
- K973214 — FRESH CELLS HFF
- K972414 — FRESHCELLS
- K960578 — ELVIS HSV GOLD
- K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
- K962311 — FRESHFROZENCELLS
- K962780 — FRESHCELLS, HEP-2
- K962782 — FRESHFROZEN CELLS, HEP-2
- K941924 — ELVIS HSV
- K936271 — FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
- K940502 — FRESH FROZEN CELLS
- K911345 — HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
- K873529 — HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.