FDA.reportPublic FDA data

AllTest Viral Transport Medium

Primary DI
06936983182287
Brand
AllTest Viral Transport Medium
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
VTM-A001
Device description
3mL, 50T EN, FDA
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242576000AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.2025-04-04JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936983182287PrimaryGS10
86936983182283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983182287069369831822876936983182287
8693698318228386936983182283

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
543254717
Device count
50
Lot or batch
true
Expiration date on label
true

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16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)1DUA-A1137C-A32026-04-15

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