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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 10 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	86-4812	FDA UDI	Class I	Active
D3	20-4760010	FDA UDI	Class I	Active
D3	20-4770010	FDA UDI	Class I	Active
D3	20-4310010	FDA UDI	Class I	Active
Lyra	Coronavirus	FDA UDI	N	Active
Fresh Cells	46-00020-DH	FDA UDI	Class I	Active
Fresh Cells	98-9696	FDA UDI	Class I	Active
Fresh Cells	53-T150	FDA UDI	Class I	Active
DHI Media & Controls	03-05050	FDA UDI	Class I	Active
Fresh Cells	44-9648C	FDA UDI	Class I	Active
Fresh Cells	92-4806	FDA UDI	Class I	Active
Fresh Cells	85-T075	FDA UDI	Class I	Active
Fresh Cells	46-0600	FDA UDI	Class I	Active
Quidel Molecular	M121	FDA UDI	Class I	Active
Thyretain	40-100200.V2	FDA UDI	Class II	Active
Fresh Cells	53-9624C	FDA UDI	Class I	Active
Fresh Cells	51-T025	FDA UDI	Class I	Active
Fresh Cells	54-4812	FDA UDI	Class I	Active
Elvis	55-2412S	FDA UDI	Class II	Active
D3 Fastpoint	01-123304	FDA UDI	Class I	Active
Ready Cells	F-54-0102-24	FDA UDI	Class I	Active
Quidel Molecular	M117	FDA UDI	Class I	Active
Fresh Cells	56-2406	FDA UDI	Class I	Active
Fresh Cells	14-308	FDA UDI	Class I	Active
Fresh Cells	51-4812	FDA UDI	Class I	Active
DHI Media & Controls	10-360500	FDA UDI	Class I	Active
D3 Ultra	01-013302.V2	FDA UDI	Class I	Active
Elvis	55-2408CB	FDA UDI	Class II	Active
Fresh Cells	54-4818	FDA UDI	Class I	Active
D3 Duet	01-205010	FDA UDI	Class I	Active
D3	20-4750010	FDA UDI	Class I	Active
Fresh Cells	56-9696	FDA UDI	Class I	Active
Fresh Cells	92-2418	FDA UDI	Class I	Active
Fresh Cells	51-2406	FDA UDI	Class I	Active
D3	20-4700010	FDA UDI	Class I	Active
Fresh Cells	56-4812	FDA UDI	Class I	Active
Elvis	10-220100	FDA UDI	Class I	Active
Fresh Cells	96-4812	FDA UDI	Class I	Active
Thyretain	40-1005K.V2	FDA UDI	Class II	Active
DHI Specimen Collection System	99-08019E	FDA UDI	Class I	Active
D3	01-013500.V2-BULK	FDA UDI	Class I	Active
DHI Specimen Collection System	405C	FDA UDI	Class I	Active
D3	01-00100	FDA UDI	Class I	Active
Fresh Cells	83-2418	FDA UDI	Class I	Active
Fresh Cells	54-T150	FDA UDI	Class I	Active
Fresh Cells	44-0600	FDA UDI	Class I	Active
Fresh Cells	75-0102	FDA UDI	Class I	Active
DHI Specimen Collection System	303CHL	FDA UDI	Class I	Active
Fresh Cells	51-T075	FDA UDI	Class I	Active
D3	01-075010	FDA UDI	Class II	Active

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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).