Visby Medical, Inc.

Address:3010 North First Street,San Jose,CA,95134,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Dna Probe, Nucleic Acid Amplification, Chlamydia (MKZ) (3) Dna-Reagents, Neisseria (LSL) (3) Trichomonas Vaginalis Nucleic Acid Amplification Test System (OUY) (3)

Premarket Exempt

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Visby Medical Sexual Health Click Test - 00810031720002 Catalog Number : PS-000688

Device Description : Visby Medical Sexual Health Click Test

Device Class :

Duns Number: 933894748

Premarket Exempt : No

Product Code : LSL, MKZ, OUY

Prescription Use : Yes

Device Count : 1

Visby Medical Power Adapter - 00810031720033 Catalog Number : PS-000288

Device Description : Visby Medical Power Adapter.

Device Class : 1

Duns Number: 933894748

Premarket Exempt : No

Product Code : LSL, MKZ, OUY

Prescription Use : Yes

Device Count : 1

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack - 00810031720057 Catalog Number : PS-000715

Device Description : Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.

Device Class : 1

Duns Number: 933894748

Premarket Exempt : No

Product Code : LSL, MKZ, OUY

Prescription Use : Yes

Device Count : 50

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