Is this your brand? Sign in to claim ownership.

Confirm Biosciences LLC

Last updated September 17, 2026

Information

Country: US
Address: 8866 Cypress Court, SAN DIEGO, CA, 92154
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3006048451
DUNS Number: —

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Healgen (Private Label) - 3124	CB-HE-3124	FDA UDI	Class II	Active
Healgen (Private Label) - 6125	CB-HE-6125	FDA UDI	Class II	Active
Healgen (Private Label) EtG Urine Dip *300ng	CB-HE-ETG 300	FDA UDI	Class II	Active
Healgen (Private Label) - 242	CB-HE-CUP-242	FDA UDI	Class II	Active
Healgen (Private Label) - 8104C	CB-HE-CUP-8104	FDA UDI	Class II	Active
Healgen (Private Label) - 1145	CB-HE-1145	FDA UDI	Class II	Active
Healgen (Private Label) - 654	CB-HE-654	FDA UDI	Class II	Active
Healgen (Private Label) - 684	CB-HE-CUP31-684	FDA UDI	Class II	Active
DrugConfirm™ Single Panel Marijuana Testing Kit	03-5601	FDA UDI	Class II	Active
DrugConfirm	CB-DC-14PanelOTC	FDA UDI	Class II	Active
Healgen (Private Label) FLATCUP-2104	CB-HE-FLATCUP-2104	FDA UDI	Class II	Active
Healgen (Private Label) - 254	CB-HE-254	FDA UDI	Class II	Active
Healgen (Private Label) - 264	CB-HE-264	FDA UDI	Class II	Active
Healgen (Private Label) - 6124	CB-HE-CUP-6124	FDA UDI	Class II	Active
DrugConfirm	CB-DC-1PanelOTC	FDA UDI	Class II	Active
Healgen (Private Label) - 6104	CB-HE-CUP31-6104	FDA UDI	Class II	Active
Healgen (Private Label) - 264	CB-HE-264	FDA UDI	Class II	Active
DrugConfirm™ 12 Panel Instant Drug Test	03-5202	FDA UDI	Class II	Active
HealthConfirm	CB-HC-Cassette-Covid Flu A/B (OTC)	FDA UDI	Class II	Active
Healgen (Private Label) 6125A3	CB-HE-CUP-6125A3C	FDA UDI	Class II	Active
Healgen (Private Label) - 6114	CB-HE-CUP31-6114	FDA UDI	Class II	Active
Healgen (Private Label) - 1125SA3C	CB-HE-CUP-1125SA3C	FDA UDI	Class II	Active
DrugConfirm	CB-DC-1PanelOTC-COC	FDA UDI	Class II	Active
Helalgen (Private Label) - 3124	CB-HE-3124	FDA UDI	Class II	Active
Healgen (Private Label) - 6124	CB-HE-9124	FDA UDI	Class II	Active
Healgen (Private Label) - 564	CB-HE-564	FDA UDI	Class II	Active
Healgen (Private Label) - 253	CB-HE-CUP-253	FDA UDI	Class II	Active
Healgen (Private Label) FLATCUP-8104	CB-HE-FLATCUP-8104	FDA UDI	Class II	Active
DrugConfirm	CB-DC-7PanelOTC	FDA UDI	Class II	Active
Healgen (Private Label) - 254	CB-HE-CUP-254	FDA UDI	Class II	Active
Healgen (Private Label) FLATCUP-6125A3	CB-HE-FLATCUP-6125A3C	FDA UDI	Class II	Active
Healgen (Private Label) - 3104	CB-HE-3104	FDA UDI	Class II	Active
Healgen (Private Label) - 7104	CB-HE-7104	FDA UDI	Class II	Active
ReliOn Home Drug Test Kit 12 Panel	RO-DR0012	FDA UDI	Class II	Active
Healgen (Private Label) - 4104	CB-HE-4104	FDA UDI	Class II	Active
Healgen (Private Label) - 3104C	CB-HE-CUP-3104	FDA UDI	Class II	Active
HealthConfirm	COVIDRev061620	FDA UDI	N/A	Active
HealthConfirm	CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK	FDA UDI	Class II	Active
DrugConfirm	CB-DC-1PANELOTCPACK2	FDA UDI	Class II	Active
DrugConfirm™ 4 Panel Instant Drug Test	03-5201	FDA UDI	Class II	Active
Healgen (Private Label) - 3124	CB-HE-CUP-3124	FDA UDI	Class II	Active
Healgen (Private Label) - 194	CB-HE-194	FDA UDI	Class II	Active
Healgen (Private Label) - 7104	CB-HE-7104	FDA UDI	Class II	Active
ReliOn 1 Panel Home Drug Test Kit	RO-DRC001	FDA UDI	Class II	Active
Healgen (Private Label) - 6125C	CB-HE-CUP-6125	FDA UDI	Class II	Active
Healgen (Private Label) FLATCUP-264	CB-HE-FLATCUP-264	FDA UDI	Class II	Active
Healgen (Private Label) - 1145	CB-HE-CUP-1145	FDA UDI	Class II	Active
DrugConfirm	CB-DC-4PanelOTC	FDA UDI	Class II	Active
Healgen (Private Label) FLATCUP-8104A3	CB-HE-FLATCUP-8104A3	FDA UDI	Class II	Active
HealthConfirm	CB-HC-Cassette-Covid Flu A/B (OTC) 2PACK	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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
Jan 29, 2021	Z-1125-2021	—	terminated	Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
Jan 29, 2021	Z-1126-2021	—	terminated	Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).