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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 6 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	49-T075	FDA UDI	Class I	Active
Elvis	55-2410S	FDA UDI	Class II	Active
Fresh Cells	54-0102L	FDA UDI	Class I	Active
Quidel Molecular	M109	FDA UDI	Class I	Active
Fresh Cells	56-9660	FDA UDI	Class I	Active
DHI Media & Controls	10-080500	FDA UDI	Class I	Active
Fresh Cells	59-0102	FDA UDI	Class I	Active
Fresh Cells	47-0600A	FDA UDI	Class I	Active
Fresh Cells	67-T075	FDA UDI	Class I	Active
Fresh Cells	44-9696	FDA UDI	Class I	Active
Ready Cells	F-87-0102-24	FDA UDI	Class I	Active
Fresh Cells	42-T075	FDA UDI	Class I	Active
DHI Media & Controls	10-390100	FDA UDI	Class I	Active
Fresh Cells	54-9696	FDA UDI	Class I	Active
Fresh Cells	96-4848	FDA UDI	Class I	Active
Fresh Cells	92-T075	FDA UDI	Class I	Active
D3	01-055005	FDA UDI	Class I	Active
D3 Fastpoint	01-123104	FDA UDI	Class I	Active
Elvis	ELVIS HSV ID / D3 Typing Test System	FDA UDI	Class II	Active
Fresh Cells	98-0101	FDA UDI	Class I	Active
Fresh Cells	44-00050	FDA UDI	Class I	Active
Ready Cells	F-96-0102-24	FDA UDI	Class I	Active
Fresh Cells	44-T150	FDA UDI	Class I	Active
Elvis	55-2424	FDA UDI	Class II	Active
D3 Fastpoint	RSV/MPV ID Kit	FDA UDI	Class II	Active
CVS Health At Home COVID-19 Test Kit	20452	FDA UDI	Class II	Active
D3	01-045005	FDA UDI	Class I	Active
Elvis	I-SK-ELVIS-100	FDA UDI	Class II	Active
Elvis	00-011085	FDA UDI	Class II	Active
Fresh Cells	53-2409	FDA UDI	Class I	Active
D3 Fastpoint	01-120002.B1	FDA UDI	Class I	Active
Fresh Cells	96-9624C	FDA UDI	Class I	Active
Elvis	55-0101	FDA UDI	Class II	Active
Fresh Cells	58-4848	FDA UDI	Class I	Active
Fresh Cells	49-4818Y	FDA UDI	Class I	Active
Fresh Cells	96-4818	FDA UDI	Class I	Active
Fresh Cells	49-2412Y	FDA UDI	Class I	Active
Fresh Cells	15-308	FDA UDI	Class I	Active
Elvis	55-2412	FDA UDI	Class II	Active
Fresh Cells	67-1212B	FDA UDI	Class I	Active
D3	20-4710010	FDA UDI	Class I	Active
Fresh Cells	57-00050	FDA UDI	Class I	Active
D3 Duet	01-215010	FDA UDI	Class I	Active
Fresh Cells	84-9696	FDA UDI	Class I	Active
D3	01-085005	FDA UDI	Class II	Active
Fresh Cells	54-2424S	FDA UDI	Class I	Active
Fresh Cells	98-2424	FDA UDI	Class I	Active
Fresh Cells	86-2424	FDA UDI	Class I	Active
Fresh Cells	53-4806	FDA UDI	Class I	Active
Thyretain	40-2000.V2	FDA UDI	Class II	Active

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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).