FDA.reportPublic FDA data

BioTeke

Primary DI
06974541563024
Brand
BioTeke
Company
Bioteke Corporation (Wuxi) Co., Ltd.
Model
ST7001-1
Published
2023-02-14
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
JSGCulture Media, Non-Selective And Non-Differential
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974541563024PrimaryGS10
86974541563020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974541563024069745415630246974541563024
8697454156302086974541563020

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560011452
Device count
50
Premarket exempt
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
06974541564526BioTekeST9001-22025-01-09
06974541563031BioTeke ST7001-12023-02-14
06974541563048BioTeke ST7001-22023-02-14
06974541563086BioTeke ST8001-12023-02-16
06974541563109BioTeke ST8001-22023-02-16
06974541563116BioTeke ST8001-22023-02-16
06974541563147BioTeke ST9001-12023-02-16
06974541563154BioTeke ST9001-12023-02-16
06974541564069BioTekeST9001-22023-02-08
06974541564403BioTekeBTK-H2205BTK-H22052024-05-27
06974541564397BioTekeBTK-H2201BTK-H22012023-09-12
06974541564380BioTekeBTK-H2202BTK-H22022023-09-04
06974541563055BioTeke ST7001-22023-02-16
06974541563093BioTeke ST8001-12023-02-16
86974541564409BioTekeBTK-H2205BTK-H22052024-05-27
06974541564373biotekeST9001-22023-05-05
06974541564335BioTeke ST7001-12023-03-07
06974541564342BioTeke ST7001-12023-03-07
86974541564331BioTeke ST7001-12023-03-07
06974541564359BioTeke ST7001-22023-03-06

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
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
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
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
16977644780005BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969859SNT BiotechShenzhen Dakewe Bio-engineering Co., LtdJSM2024-06-14
28053326002209FecalSwab®COPAN ITALIA SPAJSM2024-05-07
16974488990942iCleanHuachenyang (Shenzhen) Technology Co., LtdJSM2024-03-29
16972698600354KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-07
16972698600361KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-07
16972698600293KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-05
16972698600316KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-05
16972698600323KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-05
16972698600330KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-05
16972698600347KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSM2024-02-05
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05