Facility

Confirm Biosciences LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006048451
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device
Location	8866 Cypress Court SAN DIEGO, CA, US 92154
Registration status	Active · expires 2026
Parent company	Confirm Biosciences LLC (owner-operator 9095540)
Brand names	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Activity by year

Recalls (1)

Devices registered here (11)

Test, Propoxyphene, Over The Counter
Product code QBF (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3700
Test, Methamphetamine, Over The Counter
Product code NGG (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3610
Test, Cannabinoid, Over The Counter
Product code NFW (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3870
Test, Cocaine And Cocaine Metabolites, Over The Counter
Product code NFY (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3250
Test, Phencyclidine (Pcp), Over The Counter
Product code NGM (opens in a new tab) · Unclassified · Unknown
Test, Methadone, Over The Counter
Product code PTG (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3620
Test, Barbiturate, Over The Counter
Product code PTH (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3150
Test, Tricyclic Antidepressants, Over The Counter
Product code QAW (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3910
Test, Amphetamine, Over The Counter
Product code NFT (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3100
Test, Benzodiazepine, Over The Counter
Product code NFV (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3170
Test, Opiates, Over The Counter
Product code NGL (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3650

Recalls & enforcement

Class IITerminated2021-01-29
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…

All facilities operated by Confirm Biosciences LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Confirm Biosciences LLC (FEI 3006048451) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006048451-confirm-biosciences-llc/

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