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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 7 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	49-0600	FDA UDI	Class I	Active
Fresh Cells	83-T025	FDA UDI	Class I	Active
Fresh Cells	16-308-75	FDA UDI	Class I	Active
D3	01-057005	FDA UDI	Class I	Active
Elvis	ELVIS HSV	FDA UDI	Class II	Active
Fresh Cells	49-0600Y	FDA UDI	Class I	Active
Fresh Cells	53-9660	FDA UDI	Class I	Active
AmpliVue	M222	FDA UDI	Class I	Active
Fresh Cells	96-2418	FDA UDI	Class I	Active
Fresh Cells	64-T075	FDA UDI	Class I	Active
Fresh Cells	84-0606	FDA UDI	Class I	Active
Fresh Cells	56-T075	FDA UDI	Class I	Active
Ready Cells	05-360075	FDA UDI	Class I	Active
Solana	M122	FDA UDI	Class I	Active
Fresh Cells	83-4812	FDA UDI	Class I	Active
D3 Ultra	01-010004.V2	FDA UDI	Class I	Active
Fresh Cells	57-4824	FDA UDI	Class I	Active
DHI Specimen Collection System	406C	FDA UDI	Class I	Active
D3 Fastpoint	01-120001	FDA UDI	Class I	Active
Fresh Cells	53-00050	FDA UDI	Class I	Active
Fresh Cells	97-4816DP	FDA UDI	Class I	Active
D3	01-00060	FDA UDI	Class I	Active
Fresh Cells	53-2412	FDA UDI	Class I	Active
Fresh Cells	83-0102	FDA UDI	Class I	Active
Fresh Cells	44-T025	FDA UDI	Class I	Active
DHI Specimen Collection System	407C	FDA UDI	Class I	Active
Fresh Cells	86-0102	FDA UDI	Class I	Active
Solana	M123	FDA UDI	Class I	Active
Fresh Cells	58-4818	FDA UDI	Class I	Active
Elvis	55-0102	FDA UDI	Class II	Active
D3	01-056500-BULK	FDA UDI	Class I	Active
Quidel Molecular	M115	FDA UDI	Class I	Active
Fresh Cells	53-9696	FDA UDI	Class I	Active
Fresh Cells	51-9696	FDA UDI	Class I	Active
Fresh Cells	56-00050	FDA UDI	Class I	Active
Fresh Cells	89-T150	FDA UDI	Class I	Active
Fresh Cells	51-4818	FDA UDI	Class I	Active
Fresh Cells	67-T025	FDA UDI	Class I	Active
Fresh Cells	83-4818	FDA UDI	Class I	Active
Fresh Cells	14-309	FDA UDI	Class I	Active
Fresh Cells	67-0606B	FDA UDI	Class I	Active
Elvis	ELVIS HSV	FDA UDI	Class II	Active
Fresh Cells	49-0600A	FDA UDI	Class I	Active
Fresh Cells	97-4808DS	FDA UDI	Class I	Active
AmpliVue	M218	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08014-VCF	FDA UDI	Class I	Active
Fresh Cells	53-0600	FDA UDI	Class I	Active
Fresh Cells	87-9612C	FDA UDI	Class I	Active
Fresh Cells	67-0606	FDA UDI	Class I	Active
Fresh Cells	92-0101	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).