Facility

VISBY MEDICAL, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3016608638
Establishment type	Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	3010 North First Street San Jose, CA, US 95134
Registration status	Active · expires 2026
Parent company	Visby Medical, Inc. (owner-operator 10080245)
Brand names	Visby Medical Sexual Health Click Test

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (4)

Dna-Reagents, Neisseria
Product code LSL (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3390
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Product code QEP (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3393
Dna Probe, Nucleic Acid Amplification, Chlamydia
Product code MKZ (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3120
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Product code OUY (opens in a new tab) · Class II · Immunology · 21 CFR 866.3860

Recalls & enforcement

Class IITerminated2020-12-05
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.

FDA inspections (1)

NAI2026-04-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Visby Medical, Inc.

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. “VISBY MEDICAL, INC. (FEI 3016608638) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016608638-visby-medical-inc/

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