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DIAGNOSTIC HYBRIDS, INC.

Last updated May 24, 2026

Information

Page 14 of 14

Device	Model / Reference	Registries	Class	Status
Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification And Typing Kit, Model 01-090000	K070265	FDA 510(k)	Class II	Active
Freshfrozen Cells, Hep-2	K962782	FDA 510(k)	Class I	Active
Elvis Hsv Gold	K960578	FDA 510(k)	Class II	Active
Fresh Frozen Cells	K940502	FDA 510(k)	Class I	Active
D3 Ultra Dfa Respiratory Virus Screening & Id Kit	K061101	FDA 510(k)	Class I	Active
Fresh Cells Hff	K973214	FDA 510(k)	Class I	Active
D3 Duet Dfa Rsv/Respiratory Virus Screening Kit	K081928	FDA 510(k)	Class I	Active
D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit	K093415	FDA 510(k)	Class I	Active
Fresh Cells Llc-Mk2	K973213	FDA 510(k)	Class I	Active
Quidel Molecular Direct Hsv 1 +2/Vzv Assay	DEN140004	FDA 510(k)	Class II	Active
Dfa Respiratory Virus Screening & Id Kit	K022713	FDA 510(k)	Class I	Active
Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000	K070206	FDA 510(k)	Class II	Active
D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit	K081164	FDA 510(k)	Class II	Active
D3 Dfa Metapneumovirus Identification Kit	K090073	FDA 510(k)	Class II	Active
Fresh Cells Multi-Well Plate Cultures And Shell Vial Culture	K936271	FDA 510(k)	Class I	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 4, 2017	Z-1496-2018	—	terminated	There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Oct 26, 2016	Z-1520-2018	—	terminated	There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Jul 14, 2016	Z-1797-2018	—	terminated	There is a possibility of low volume and/or leaking standard bottles.
Nov 3, 2015	Z-1498-2018	—	terminated	A component of the kit was found to contain bacterial contamination.
Nov 3, 2015	Z-1499-2018	—	terminated	A component of the kit was found to contain bacterial contamination.
Nov 3, 2015	Z-1497-2018	—	terminated	A component of the kit was found to contain bacterial contamination.
Oct 16, 2014	Z-0417-2015	—	terminated	Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Dec 31, 2012	Z-0792-2013	—	terminated	RhMK product fungal contamination.
Jan 21, 2009	Z-0822-2010	—	terminated	During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).