FDA.reportPublic FDA data

iClean

Primary DI
26974488990048
Brand
iClean
Company
Huachenyang (Shenzhen) Technology Co., Ltd
Model
CY-F005-20
Catalog number
CY-B-F005-20
Device description
The product consists of a tube with viral transport medium, one piece of sterile sampling swab and one piece of biobag
Published
2022-11-01
Public version status
Update
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
K212856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212856000iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co. , Ltd.2022-08-18JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974488990048PrimaryGS10
16974488990041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697448899004826974488990048
1697448899004116974488990041

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Regulatory Flags#

DUNS number
548237157
Device count
100
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974488991055iCleanCY-960002024-05-30
16974488991062iCleanCY-98000DM2024-05-30
26974488991052iCleanCY-960002024-05-30
26974488991069iCleanCY-98000DM2024-05-30
16974488991048iCleanCY-98000T2024-04-23
26974488991045iCleanCY-98000T2024-04-23
16974488991000iCleanCY-930502024-04-15
16974488991024iCleanCY-960002024-04-15
26974488991007iCleanCY-930502024-04-15
26974488991021iCleanCY-960002024-04-15
16974488990935iCleanCY-90001-FS2024-03-29
16974488990942iCleanCY-F003-40 (NGS)2024-03-29
16974488990959iCleanCY-B-F005-202024-03-29
16974488990966iCleanCY-B-F005-202024-03-29
16974488990973iCleanCY-7422024-03-29
16974488990980iCleanCY-F003-30 (Amies)2024-03-29
16974488990997iCleanCY-F003-30 (Amies)2024-03-29
26974488990932iCleanCY-90001-FS2024-03-29
26974488990949iCleanCY-F003-40 (NGS)2024-03-29
26974488990956iCleanCY-B-F005-202024-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973471962171BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962188BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962195BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962201BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962218BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962225BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962232BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962249BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962256BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
00810164510815Atida Viral Transport Medium (Non-inactivated Type)ACESO LABORATORIES INC.JSM2026-03-23
38053326011826BD FCTCOPAN ITALIA SPAJSM2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
00816576026067TransPROHARDY DIAGNOSTICSJSM2024-10-08
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
16973471969941BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969996BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23