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DIAGNOSTIC HYBRIDS, INC.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: quidel.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(858)552-1100
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117359612

Catalogue (665)

Page 2 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	97-2412S	FDA UDI	Class I	Active
Fresh Cells	84-4812	FDA UDI	Class I	Active
D3	01-014010	FDA UDI	Class I	Active
DHI Media & Controls	10-200100EU1	FDA UDI	Class I	Active
DHI Media & Controls	10-120500	FDA UDI	Class I	Active
Fresh Cells	89-T075	FDA UDI	Class I	Active
D3	20-4810020	FDA UDI	Class I	Active
DHI Media & Controls	10-170500	FDA UDI	Class I	Active
Fresh Cells	56-0600L	FDA UDI	Class I	Active
Fresh Cells	98-4836C	FDA UDI	Class I	Active
Fresh Cells	51-9624C	FDA UDI	Class I	Active
D3	20-4600010	FDA UDI	Class I	Active
Savanna	M409-4	FDA UDI	Class II	Active
Fresh Cells	57-9696	FDA UDI	Class I	Active
Fresh Cells	96-2406	FDA UDI	Class I	Active
Fresh Cells	62-00050	FDA UDI	Class I	Active
Fresh Cells	54-2412	FDA UDI	Class I	Active
Fresh Cells	62-T150	FDA UDI	Class I	Active
Fresh Cells	53-T025-50	FDA UDI	Class I	Active
Fresh Cells	56-9624C	FDA UDI	Class I	Active
Fresh Cells	76-T075	FDA UDI	Class I	Active
D3	20-4900010	FDA UDI	Class I	Active
DHI Media & Controls	10-151000	FDA UDI	Class I	Active
Fresh Cells	72-0600	FDA UDI	Class I	Active
Fresh Cells	51-2412	FDA UDI	Class I	Active
Fresh Cells	84-9648C	FDA UDI	Class I	Active
D3	DFA HSV ID Kit	FDA UDI	Class II	Active
D3 Ultra	01-010001.V2	FDA UDI	Class I	Active
Fresh Cells	98-9612C	FDA UDI	Class I	Active
Fresh Cells	92-2412S	FDA UDI	Class I	Active
Fresh Cells	48-0600P	FDA UDI	Class I	Active
D3 Ultra	01-013102.V2	FDA UDI	Class I	Active
Fresh Cells	87-9696	FDA UDI	Class I	Active
Thyretain	40-540050.V2	FDA UDI	Class II	Active
Fresh Cells	49-T150A	FDA UDI	Class I	Active
AmpliVue	M221	FDA UDI	Class I	Active
Fresh Cells	67-9696	FDA UDI	Class I	Active
Fresh Cells	44-0102	FDA UDI	Class I	Active
Fresh Cells	83-384384	FDA UDI	Class I	Active
DHI Media & Controls	10-200100	FDA UDI	Class I	Active
Savanna	20445	FDA UDI	Class II	Active
DHI Specimen Collection System	99-08018A	FDA UDI	Class I	Active
Elvis	00-013003.V2	FDA UDI	Class II	Active
DHI Media & Controls	10-350500	FDA UDI	Class I	Active
Fresh Cells	C49-T150A	FDA UDI	Class I	Active
Fresh Cells	58-4806	FDA UDI	Class I	Active
Fresh Cells	53-0102	FDA UDI	Class I	Active
D3 Fastpoint	01-120001.B1	FDA UDI	Class I	Active
Fresh Cells	83-9660	FDA UDI	Class I	Active
D3 Duet	01-215002	FDA UDI	Class I	Active

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Notified Bodies

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Authorities

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FDA Recalls (9)

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).