FDA.reportPublic FDA data

Visby Medical Respiratory Health

Primary DI
10810031720016
Brand
Visby Medical Respiratory Health
Company
Visby Medical, Inc.
Model
PS-300708
Catalog number
PS-400005
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810031720016PackageGS110In Commercial Distribution
00810031720019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003172001610810031720016
00810031720019008100317200198100317200190810031720019

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933894748
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackPS-000715PS-0007152021-09-15

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05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
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04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
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