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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 12 of 14

Device	Model / Reference	Registries	Class	Status
DHI Specimen Collection System	410C	FDA UDI	Class I	Active
AmpliVue	M214	FDA UDI	Class I	Active
Fresh Cells	48-T075P	FDA UDI	Class I	Active
D3 Ultra	01-013702.V2	FDA UDI	Class I	Active
Fresh Cells	49-4806Y	FDA UDI	Class I	Active
DHI Media & Controls	10-310100	FDA UDI	Class I	Active
Elvis	55-2406DE	FDA UDI	Class II	Active
Fresh Cells	49-2406A	FDA UDI	Class I	Active
Fresh Cells	51-00125C	FDA UDI	Class I	Active
Fresh Cells	59-0600	FDA UDI	Class I	Active
D3 Ultra	01-010002.V2	FDA UDI	Class I	Active
DHI Specimen Collection System	404C	FDA UDI	Class I	Active
Fresh Cells	49-0102A	FDA UDI	Class I	Active
Fresh Cells	97-0606	FDA UDI	Class I	Active
DHI Media & Controls	03-05000	FDA UDI	Class I	Active
Fresh Cells	50-91-9696-90	FDA UDI	Class I	Active
Fresh Cells	16-309-75	FDA UDI	Class I	Active
Fresh Cells	92-0606	FDA UDI	Class I	Active
Fresh Cells	51-2409	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08015-VCF	FDA UDI	Class I	Active
Fresh Cells	54-2406	FDA UDI	Class I	Active
Fresh Cells	92-4812	FDA UDI	Class I	Active
D3	DFA Metapneumovirus Kit	FDA UDI	Class II	Active
Solana	M308	FDA UDI	Class II	Active
Fresh Cells	78-T025AF	FDA UDI	Class I	Active
D3	01-096005	FDA UDI	Class II	Active
Fresh Cells	53-T075C	FDA UDI	Class I	Active
Fresh Cells	97-2424S	FDA UDI	Class I	Active
Fresh Cells	51-T150	FDA UDI	Class I	Active
D3	01-00070.v2	FDA UDI	Class I	Active
Fresh Cells	59-T075	FDA UDI	Class I	Active
Fresh Cells	98-2418	FDA UDI	Class I	Active
D3 Duet	01-210000	FDA UDI	Class I	Active
Fresh Cells	49-4848	FDA UDI	Class I	Active
Fresh Cells	76-0600L	FDA UDI	Class I	Active
Solana	M305	FDA UDI	Class II	Active
Thyretain	40-300500.V2	FDA UDI	Class II	Active
Fresh Cells	92-9660	FDA UDI	Class I	Active
Fresh Cells	51-4824	FDA UDI	Class I	Active
D3 Ultra	01-013502.V2	FDA UDI	Class I	Active
Fresh Cells	84-4824	FDA UDI	Class I	Active
Fresh Cells	83-T225DH	FDA UDI	Class I	Active
DHI Media & Controls	03-05130	FDA UDI	Class I	Active
Fresh Cells	97-2406	FDA UDI	Class I	Active
Fresh Cells	58-9696B	FDA UDI	Class I	Active
D3	01-015010	FDA UDI	Class I	Active
DHI Media & Controls	10-080100	FDA UDI	Class I	Active
Fresh Cells	76-T025	FDA UDI	Class I	Active
Fresh Cells	97-9660	FDA UDI	Class I	Active
Fresh Cells	58-2424	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).