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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 5 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	49-2412A	FDA UDI	Class I	Active
Fresh Cells	56-0600	FDA UDI	Class I	Active
Elvis	55-2418S	FDA UDI	Class II	Active
D3 Fastpoint	01-120001.B2	FDA UDI	Class I	Active
Quidel Molecular	M116	FDA UDI	Class I	Active
Fresh Cells	86-T075	FDA UDI	Class I	Active
Fresh Cells	97-0102	FDA UDI	Class I	Active
Fresh Cells	84-1212B	FDA UDI	Class I	Active
Quidel Molecular	M106	FDA UDI	Class I	Active
Fresh Cells	51-0600	FDA UDI	Class I	Active
DHI Specimen Collection System	601	FDA UDI	Class I	Active
DHI Media & Controls	03-05300	FDA UDI	Class I	Active
Fresh Cells	97-9648	FDA UDI	Class I	Active
Fresh Cells	51-2424	FDA UDI	Class I	Active
Fresh Cells	58-0606	FDA UDI	Class I	Active
DHI Media & Controls	10-010100	FDA UDI	Class I	Active
Fresh Cells	98-9624C	FDA UDI	Class I	Active
DHI Media & Controls	10-090100	FDA UDI	Class I	Active
Fresh Cells	49-T075A	FDA UDI	Class I	Active
Fresh Cells	51-0101	FDA UDI	Class I	Active
Elvis	I-SKT-ELVIS-60.V2	FDA UDI	Class II	Active
Elvis	10-220500	FDA UDI	Class I	Active
DHI Media & Controls	10-030010	FDA UDI	Class I	Active
Fresh Cells	54-4824	FDA UDI	Class I	Active
D3	01-013200.V2-BULK	FDA UDI	Class I	Active
Fresh Cells	49-T025A	FDA UDI	Class I	Active
Fresh Cells	51-4806C	FDA UDI	Class I	Active
D3	01-095005	FDA UDI	Class II	Active
Fresh Cells	57-0102	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08024	FDA UDI	Class I	Active
D3	01-050000-BULK	FDA UDI	Class I	Active
D3	01-00050	FDA UDI	Class I	Active
Fresh Cells	96-2424	FDA UDI	Class I	Active
Fresh Cells	67-0606L	FDA UDI	Class I	Active
Fresh Cells	53-T075	FDA UDI	Class I	Active
Fresh Cells	98-4812	FDA UDI	Class I	Active
Thyretain	40-E2610.V2	FDA UDI	Class II	Active
D3	20-4820020	FDA UDI	Class I	Active
Ready Cells	05-370100	FDA UDI	Class I	Active
Fresh Cells	92-9624C	FDA UDI	Class I	Active
Fresh Cells	72-9624C	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08011.VCM	FDA UDI	Class I	Active
Fresh Cells	72-T075	FDA UDI	Class I	Active
AmpliVue	M215	FDA UDI	Class I	Active
Fresh Cells	46-0600A	FDA UDI	Class I	Active
Fresh Cells	98-0102	FDA UDI	Class I	Active
Fresh Cells	96-0606	FDA UDI	Class I	Active
Fresh Cells	92-2424S	FDA UDI	Class I	Active
D3	01-050000	FDA UDI	Class I	Active
DHI Specimen Collection System	403C	FDA UDI	Class I	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).