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Cue Health Inc.

United States·US-MF-000024397

Last updated September 18, 2026

What Cue Health Inc. makes

Cue Health Inc. manufactures in vitro diagnostic (IVD) devices for home and clinical specimen collection, including capillary blood, faecal, general clinical, and urine samples. Their product line includes tests for allergy screening, kidney and liver function, fertility, heart disease risk, vitamin deficiencies, cholesterol levels, and infectious diseases like herpes and colon cancer screening. The company also provides reusable sample collection kits for at-home use.

The company’s devices are classified under FDA categories as Class I and Class II, with regulatory submissions including 510(k) clearances and De Novo authorisations. These products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 4980, Carroll Canyon Road, San Diego, United States
Website: cuehealth.com/
This website did not respond when we last checked — the domain may no longer be active. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (833) 283-8378
PRRC Contact: Roderick Castillo
EUDAMED SRN: US-MF-000024397
FDA FEI Number: —
DUNS Number: 081257070

Catalogue (29)

Device	Model / Reference	Registries	Class	Status
Cue Sample Collection Kit	C2241	FDA UDI	Class I	Active
Indoor + Outdoor Allergy Test	C2253	FDA UDI	Class II	Active
Kidney Function Test	C2236	FDA UDI	N/A	Active
Fertility Test for Women	C2227	FDA UDI	Class II	Active
Liver Function Test	C2233	FDA UDI	Class II	Active
Heart Disease Risk Test: Lipoprotein a + ApoB	C2225	FDA UDI	Class II	Active
Herpes Test	C2231	FDA UDI	Class II	Active
Colon Cancer Screening Test	C2235	FDA UDI	Class I	Active
Heart Health + Metabolic Test	C2248	FDA UDI	Class II	Active
Vitamin D Test	C2232	FDA UDI	Class II	Active
Premium Heart Health + Cholesterol Test	C2256	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2240	FDA UDI	Class I	Active
Food Sensitivity Test	C2234	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2242	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2239	FDA UDI	Class II	Active
Women's Health Test	C2226	FDA UDI	Class II	Active
Hepatitis C Test	C2250	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2244	FDA UDI	Class II	Active
Celiac Disease Test	C2247	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2243	FDA UDI	Class II	Active
Glucose + Insulin Test	C2246	FDA UDI	Class II	Active
Heart Health + Cholesterol Test	C2224	FDA UDI	Class II	Active
Food Allergy Test	C2252	FDA UDI	Class II	Active
Cue Sample Collection Kit	C2238	FDA UDI	Class II	Active
Thyroid Test	C2251	FDA UDI	Class II	Active
Men's Health Test	C2245	FDA UDI	Class II	Active
HIV Test	C2249	FDA UDI	Class II	Active
Cue COVID-19 Molecular Test	DEN220028	FDA 510(k)	Class II	Active
Cue COVID-19 Molecular Test	K232643	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cue Health Inc. has one FDA recall record initiated on 2024-05-24, with the recall listed as both open and classified. The reason stated is that modified test kits were marketed and distributed without required FDA approval, clearance, or authorization.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 24, 2024	Z-0091-2025	—	open, classified	Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.