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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 1 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	51-2418	FDA UDI	Class I	Active
D3	01-035002	FDA UDI	Class II	Active
Fresh Cells	84-2418	FDA UDI	Class I	Active
Fresh Cells	51-00050	FDA UDI	Class I	Active
Fresh Cells	56-0606	FDA UDI	Class I	Active
Fresh Cells	72-00050	FDA UDI	Class I	Active
Thyretain	40-100100	FDA UDI	Class II	Active
D3 Fastpoint	01-122006	FDA UDI	Class I	Active
Fresh Cells	67-T150	FDA UDI	Class I	Active
Fresh Cells	84-T025	FDA UDI	Class I	Active
Fresh Cells	53-2406	FDA UDI	Class I	Active
Fresh Cells	98-4824	FDA UDI	Class I	Active
Fresh Cells	53-2424	FDA UDI	Class I	Active
Fresh Cells	58-2412	FDA UDI	Class I	Active
Fresh Cells	52-T075	FDA UDI	Class I	Active
DHI Media & Controls	10-100007	FDA UDI	Class I	Active
Fresh Cells	56-2412	FDA UDI	Class I	Active
Fresh Cells	87-00050	FDA UDI	Class I	Active
Fresh Cells	83-T075	FDA UDI	Class I	Active
Fresh Cells	84-2424	FDA UDI	Class I	Active
Thyretain	40-3000.V2	FDA UDI	Class II	Active
D3	01-058005	FDA UDI	Class I	Active
Fresh Cells	54-4836C	FDA UDI	Class I	Active
Fresh Cells	98-4806	FDA UDI	Class I	Active
Fresh Cells	96-9660	FDA UDI	Class I	Active
Thyretain	40-1025.V2	FDA UDI	Class II	Active
D3	01-056005	FDA UDI	Class I	Active
Fresh Cells	56-4824	FDA UDI	Class I	Active
D3	01-035005	FDA UDI	Class II	Active
Fresh Cells	92-4808DS	FDA UDI	Class I	Active
Fresh Cells	57-T075	FDA UDI	Class I	Active
Fresh Cells	98-4818	FDA UDI	Class I	Active
Fresh Cells	97-9696	FDA UDI	Class I	Active
D3	20-4740010	FDA UDI	Class I	Active
Fresh Cells	78-T075	FDA UDI	Class I	Active
Fresh Cells	85-2412	FDA UDI	Class I	Active
Fresh Cells	98-4808DS	FDA UDI	Class I	Active
Fresh Cells	53-4824	FDA UDI	Class I	Active
Fresh Cells	46-T075	FDA UDI	Class I	Active
Fresh Cells	54-0102	FDA UDI	Class I	Active
Fresh Cells	70-T225	FDA UDI	Class I	Active
Fresh Cells	75-T225	FDA UDI	Class I	Active
Quidel Molecular	M107	FDA UDI	Class I	Active
Fresh Cells	51-0620EU	FDA UDI	Class I	Active
Fresh Cells	92-2412	FDA UDI	Class I	Active
Fresh Cells	44-2424	FDA UDI	Class I	Active
D3	DFA Chlamydiae Kit	FDA UDI	Class I	Active
Fresh Cells	84-00050	FDA UDI	Class I	Active
DHI Media & Controls	10-330100	FDA UDI	Class I	Active
Fresh Cells	96-9648C	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).