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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 13 of 14

Device	Model / Reference	Registries	Class	Status
DHI Specimen Collection System	409C	FDA UDI	Class I	Active
Fresh Cells	89-00050	FDA UDI	Class I	Active
Fresh Cells	53-4812	FDA UDI	Class I	Active
Fresh Cells	98-4812C	FDA UDI	Class I	Active
Fresh Cells	56-9632C	FDA UDI	Class I	Active
Quidel Molecular	M108	FDA UDI	Class I	Active
D3 Ultra	01-010003.V2	FDA UDI	Class I	Active
D3 Ultra	01-013402.V2	FDA UDI	Class I	Active
Fresh Cells	57-4848	FDA UDI	Class I	Active
Fresh Cells	51-9660	FDA UDI	Class I	Active
Solana	M302	FDA UDI	Class II	Active
DHI Media & Controls	10-330500	FDA UDI	Class I	Active
Fresh Cells	49-9624YC	FDA UDI	Class I	Active
Fresh Cells	97-00050	FDA UDI	Class I	Active
Fresh Cells	51-T225	FDA UDI	Class I	Active
Elvis	55-2424S	FDA UDI	Class II	Active
Fresh Cells	85-9696	FDA UDI	Class I	Active
Fresh Cells	76-00050	FDA UDI	Class I	Active
Fresh Cells	96-2424S	FDA UDI	Class I	Active
Fresh Cells	98-2409	FDA UDI	Class I	Active
Fresh Cells	62-0102	FDA UDI	Class I	Active
Fresh Cells	18-309-24	FDA UDI	Class I	Active
DHI Media & Controls	10-390500	FDA UDI	Class I	Active
DHI Specimen Collection System	602	FDA UDI	Class I	Active
DHI Specimen Collection System	401C	FDA UDI	Class I	Active
CVS Health At Home COVID-19 Test Kit	20452	FDA UDI	Class II	Active
Solana	M311	FDA UDI	Class I	Active
DHI Media & Controls	10-210125	FDA UDI	Class I	Active
Fresh Cells Vero	K973209	FDA 510(k)	Class I	Active
D3 Fastpoint L-Dfa Rsv/Mvp Identification Kit	K093233	FDA 510(k)	Class II	Active
Modification To D3 Ultra Dfa Respiratory Virus Screening & Id Kit	K092300	FDA 510(k)	Class I	Active
Freshcells	K972414	FDA 510(k)	Class I	Active
Freshfrozencells	K962311	FDA 510(k)	Class I	Active
Elvis Hsv Id And D3 Typing Test System	K091753	FDA 510(k)	Class II	Active
Thyretain Tm Tsi Reporter Bioassay	K092229	FDA 510(k)	Class II	Active
Thyroid Stimulating Immunoglobulin Reporter Assay	K083391	FDA 510(k)	Class II	Active
Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit	K063675	FDA 510(k)	Class I	Active
Elvis Hsv	K941924	FDA 510(k)	Class II	Active
Fresh Cells Mv1lu	K973211	FDA 510(k)	Class I	Active
Hybriwick System: Herpes Dna Probe Test Kit	K873529	FDA 510(k)	Class II	Active
Hsv In Situ Dna Probe Hybridization Test Kit	K911345	FDA 510(k)	Class II	Active
D3 Ultra Duet Dfa Respiratory Virus Identification Kit	K091171	FDA 510(k)	Class II	Active
Freshcells, Hep-2	K962780	FDA 510(k)	Class I	Active
Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000	K063798	FDA 510(k)	Class II	Active
Fresh Cells Nci H292	K973210	FDA 510(k)	Class I	Active
D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification Kit	K092882	FDA 510(k)	Class I	Active
Fresh Cells Wi-38	K973212	FDA 510(k)	Class I	Active
D3 Duet Dfa Influenza A/Respiratory Virus Screening Kit	K081746	FDA 510(k)	Class I	Active
Elvis Hsv Id/Typing Test System	K971662	FDA 510(k)	Class II	Active
Fresh Cells Multi-Well & Shell Vial Cultures	K962306	FDA 510(k)	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).