Visby Medical Sexual Health Click Test PS-000688

GUDID 00810031720002

Visby Medical Sexual Health Click Test

Visby Medical, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Primary Device ID00810031720002
NIH Device Record Keya3d86d9f-edfc-4190-9f2e-a09dc338c466
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisby Medical Sexual Health Click Test
Version Model Number000175
Catalog NumberPS-000688
Company DUNS933894748
Company NameVisby Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810031720002 [Primary]
GS110810031720009 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSLDna-Reagents, Neisseria

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-23
Device Publish Date2021-09-15

Devices Manufactured by Visby Medical, Inc.

10810031720061 - Visby Medical Sexual Health Test2023-04-27
00810031720071 - Visby Medical Power Adapter, Right Angle2023-04-27
00810031720002 - Visby Medical Sexual Health Click Test2021-09-23Visby Medical Sexual Health Click Test
00810031720002 - Visby Medical Sexual Health Click Test2021-09-23 Visby Medical Sexual Health Click Test
00810031720033 - Visby Medical Power Adapter2021-09-23 Visby Medical Power Adapter.
00810031720057 - Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack2021-09-23 Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.

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