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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 4 of 14

Device	Model / Reference	Registries	Class	Status
Fresh Cells	83-0606	FDA UDI	Class I	Active
Fresh Cells	96-2412	FDA UDI	Class I	Active
Fresh Cells	83-0600	FDA UDI	Class I	Active
Fresh Cells	96-4806	FDA UDI	Class I	Active
DHI Media & Controls	10-120100	FDA UDI	Class I	Active
D3 Ultra	01-010000.V2	FDA UDI	Class I	Active
Elvis	ELVIS HSV	FDA UDI	Class II	Active
Fresh Cells	51-T075C	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08011.V2	FDA UDI	Class I	Active
Fresh Cells	99-84121903-T150	FDA UDI	Class I	Active
Fresh Cells	99-84121903-9660	FDA UDI	Class I	Active
Fresh Cells	56-4848	FDA UDI	Class I	Active
D3 Fastpoint	01-123504	FDA UDI	Class I	Active
Fresh Cells	54-2412S	FDA UDI	Class I	Active
Fresh Cells	96-4810DL	FDA UDI	Class I	Active
DHI Media & Controls	10-350100	FDA UDI	Class I	Active
Fresh Cells	96-0102	FDA UDI	Class I	Active
Fresh Cells	52-0600	FDA UDI	Class I	Active
Fresh Cells	58-0102	FDA UDI	Class I	Active
Fresh Cells	84-2412	FDA UDI	Class I	Active
Fresh Cells	92-4818	FDA UDI	Class I	Active
Fresh Cells	99-84121903-T075	FDA UDI	Class I	Active
Fresh Cells	49-2424	FDA UDI	Class I	Active
Fresh Cells	51-9648	FDA UDI	Class I	Active
Elvis	55-2409	FDA UDI	Class II	Active
Fresh Cells	52-T150	FDA UDI	Class I	Active
Fresh Cells	96-T075	FDA UDI	Class I	Active
Fresh Cells	84-0600	FDA UDI	Class I	Active
Fresh Cells	58-4812	FDA UDI	Class I	Active
D3 Ultra	01-013602.V2	FDA UDI	Class I	Active
Fresh Cells	53-4818	FDA UDI	Class I	Active
Fresh Cells	49-4812Y	FDA UDI	Class I	Active
Fresh Cells	51-9630	FDA UDI	Class I	Active
Thyretain	40-300200	FDA UDI	Class II	Active
Fresh Cells	72-9696	FDA UDI	Class I	Active
Elvis	00-001026	FDA UDI	Class II	Active
D3 Fastpoint	01-120000.B1	FDA UDI	Class I	Active
Solana	M307	FDA UDI	Class II	Active
Fresh Cells	57-2406	FDA UDI	Class I	Active
Fresh Cells	54-4848	FDA UDI	Class I	Active
DHI Specimen Collection System	99-08012.V2	FDA UDI	Class I	Active
Savanna	20382	FDA UDI	Class II	Active
Fresh Cells	98-2406	FDA UDI	Class I	Active
Fresh Cells	44-9612	FDA UDI	Class I	Active
Fresh Cells	57-0600	FDA UDI	Class I	Active
Thyretain	Thyretain	FDA UDI	Class II	Active
DHI Specimen Collection System	408C	FDA UDI	Class I	Active
Fresh Cells	98-2412	FDA UDI	Class I	Active
D3	01-002007b	FDA UDI	Class I	Active
DHI Specimen Collection System	402C	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).