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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 9 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	48-0102P	FDA UDI	Class I	Active
Fresh Cells	97-4806	FDA UDI	Class I	Active
Fresh Cells	54-00050	FDA UDI	Class I	Active
Fresh Cells	84-T150	FDA UDI	Class I	Active
Fresh Cells	52-0606	FDA UDI	Class I	Active
Fresh Cells	99-84121903-9696	FDA UDI	Class I	Active
Fresh Cells	84-0101	FDA UDI	Class I	Active
Fresh Cells	49-2424Y	FDA UDI	Class I	Active
DHI Media & Controls	10-290030	FDA UDI	Class I	Active
Quidel Molecular	M110	FDA UDI	Class I	Active
Fresh Cells	96-4824	FDA UDI	Class I	Active
D3	20-4780010	FDA UDI	Class I	Active
Fresh Cells	85-T025	FDA UDI	Class I	Active
DHI Specimen Collection System	411C	FDA UDI	Class I	Active
Fresh Cells	49-00010P	FDA UDI	Class I	Active
Fresh Cells	97-4824	FDA UDI	Class I	Active
D3 Fastpoint	Respiratory Virus ID Kit	FDA UDI	Class I	Active
Fresh Cells	87-0600	FDA UDI	Class I	Active
Savanna	20382R	FDA UDI	Class II	Active
Solana	M118	FDA UDI	Class I	Active
Elvis	00-011015	FDA UDI	Class II	Active
Fresh Cells	54-4806	FDA UDI	Class I	Active
D3 Ultra	01-010006.V2	FDA UDI	Class I	Active
Fresh Cells	83-9696	FDA UDI	Class I	Active
Thyretain	40-400100	FDA UDI	Class II	Active
Fresh Cells	58-T150	FDA UDI	Class I	Active
Fresh Cells	58-2418	FDA UDI	Class I	Active
Fresh Cells	84-T025AF	FDA UDI	Class I	Active
D3	01-050001	FDA UDI	Class I	Active
Fresh Cells	52-2424	FDA UDI	Class I	Active
Elvis	ELVIS HSV	FDA UDI	Class II	Active
DHI Media & Controls	10-200100EU2	FDA UDI	Class I	Active
Fresh Cells	C49-0102A	FDA UDI	Class I	Active
Fresh Cells	56-T025	FDA UDI	Class I	Active
D3	01-0550025	FDA UDI	Class I	Active
D3	01-025005	FDA UDI	Class II	Active
D3	01-002015	FDA UDI	Class I	Active
D3	01-00010	FDA UDI	Class I	Active
Fresh Cells	83-2412	FDA UDI	Class I	Active
Fresh Cells	75-T075	FDA UDI	Class I	Active
Fresh Cells	47-0600	FDA UDI	Class I	Active
Fresh Cells	53-T225	FDA UDI	Class I	Active
Fresh Cells	58-T075	FDA UDI	Class I	Active
Fresh Cells	96-00050	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08019A	FDA UDI	Class I	Active
DHI Media & Controls	10-340100	FDA UDI	Class I	Active
D3 Ultra	01-013100.V2-BULK	FDA UDI	Class I	Active
Fresh Cells	96-9632C	FDA UDI	Class I	Active
Fresh Cells	99-84121903-384384	FDA UDI	Class I	Active
Fresh Cells	92-00050	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).