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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 8 of 14

Device	Model / Reference	Registries	Class	Status
Elvis	55-2418	FDA UDI	Class II	Active
Fresh Cells	96-0101	FDA UDI	Class I	Active
D3 Fastpoint	01-124110	FDA UDI	Class I	Active
Fresh Cells	57-2424	FDA UDI	Class I	Active
Fresh Cells	58-4824	FDA UDI	Class I	Active
Fresh Cells	49-0102Y	FDA UDI	Class I	Active
Fresh Cells	56-2424	FDA UDI	Class I	Active
DHI Media & Controls	10-020100	FDA UDI	Class I	Active
Elvis	55-2408DF	FDA UDI	Class II	Active
Fresh Cells	76-0600R	FDA UDI	Class I	Active
Fresh Cells	97-2424	FDA UDI	Class I	Active
Fresh Cells	56-T150	FDA UDI	Class I	Active
D3	DFA HSV ID and Typing ID Kit	FDA UDI	Class II	Active
Fresh Cells	51-4806	FDA UDI	Class I	Active
Fresh Cells	92-2406	FDA UDI	Class I	Active
Savanna	M409-1	FDA UDI	Class II	Active
Solana	M306	FDA UDI	Class II	Active
Fresh Cells	83-4824	FDA UDI	Class I	Active
Fresh Cells	86-9660	FDA UDI	Class I	Active
Fresh Cells	46-T150	FDA UDI	Class I	Active
D3 Ultra	01-013010.V2	FDA UDI	Class I	Active
Elvis	55-2406S	FDA UDI	Class II	Active
Elvis	ELVIS HSV ID / D3 Typing Test System	FDA UDI	Class II	Active
Fresh Cells	97-4848	FDA UDI	Class I	Active
Fresh Cells	44-T075	FDA UDI	Class I	Active
Fresh Cells	51-T150C	FDA UDI	Class I	Active
Fresh Cells	85-9648	FDA UDI	Class I	Active
Fresh Cells	75-T150	FDA UDI	Class I	Active
Thyretain	40-1050.V2	FDA UDI	Class II	Active
D3 Ultra	01-013202.V2	FDA UDI	Class I	Active
Fresh Cells	51-4848	FDA UDI	Class I	Active
Fresh Cells	87-0102	FDA UDI	Class I	Active
D3	01-320000	FDA UDI	Class I	Active
Fresh Cells	86-9696	FDA UDI	Class I	Active
D3 Ultra	01-010007.V2	FDA UDI	Class I	Active
Fresh Cells	85-2424	FDA UDI	Class I	Active
Thyretain	40-530050.V2	FDA UDI	Class II	Active
Fresh Cells	49-0102	FDA UDI	Class I	Active
Fresh Cells	97-4812	FDA UDI	Class I	Active
Fresh Cells	54-2424	FDA UDI	Class I	Active
Fresh Cells	91-9696	FDA UDI	Class I	Active
D3	01-001025	FDA UDI	Class I	Active
Quidel Molecular	M119	FDA UDI	Class I	Active
Fresh Cells	96-9696	FDA UDI	Class I	Active
Fresh Cells	49-T225DH	FDA UDI	Class I	Active
Fresh Cells	92-4812DC	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08021	FDA UDI	Class I	Active
D3 Duet	01-200000	FDA UDI	Class I	Active
Fresh Cells	86-4824	FDA UDI	Class I	Active
Fresh Cells	43-T150	FDA UDI	Class I	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).