FDA.reportPublic FDA data

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack

Primary DI
00810031720057
Brand
Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack
Company
Visby Medical, Inc.
Model
PS-000715
Catalog number
PS-000715
Device description
Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.
Published
2021-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LSLDna-Reagents, Neisseria
MKZDna Probe, Nucleic Acid Amplification, Chlamydia
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200748000Visby Medical Sexual HealthVisby Medical2021-08-26QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810031720057PrimaryGS10
00810031720002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810031720057008100317200578100317200570810031720057
00810031720002008100317200028100317200020810031720002

GMDN Terms#

Term, Definition table
TermDefinition
Sexually transmitted infection (STI) testing specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933894748
Device count
50
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810031720125Visby Medical Men’s Sexual Health TestPS-400314PS-4007212025-10-23
00810031720088Visby Medical Women's Sexual Health TestPS-4001452025-08-07
00810031720019Visby Medical Respiratory Health PS-300708PS-4000052025-03-19
10810031720016Visby Medical Respiratory Health PS-300708PS-4000052025-03-19
00810031720002Visby Medical Sexual Health Click Test000175PS-0006882021-09-15
00810031720064Visby Medical Sexual Health TestPS-001402PS-3006812023-04-19
10810031720061Visby Medical Sexual Health TestPS-001402PS-3006812023-04-19
00810031720071Visby Medical Power Adapter, Right AnglePS-000855PS-0008552023-04-19
00810031720033Visby Medical Power AdapterPS-000288PS-0002882021-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00875197007268cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.LSL2026-02-24
00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYLSL2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-23
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-23
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
00382904439231BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
15420045511880Aptima®Hologic, Inc.MKZ2023-10-26
15420045511880Aptima®Hologic, Inc.LSL2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.OUY2023-09-14
00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
00884999051096Alinity mABBOTT MOLECULAR INC.LSL2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.MKZ2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.LSL2023-04-19
15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514966APTIMAHologic, Inc.LSL2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28