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ST9001/ST8001
BioTeke
Warm Warning:This product is not available for US market.
A.Description
The sampling swab uses advanced jet implanted nylon fuzz technology. Compared with conventional fiber swabs, the sample is easily penetrated, diluted, and trapped in the fiber. The nylon flocking swab has outstanding sample collection and release capability, and the release rate can reach 90%, which is much higher than that of the conventional fiber swab.
Light red media formation contains antibiotics that can effectively inhibit the reproduction of bacteria and fungi.
B.Advantage&Features
1. Rapid preservation of viral nucleic acids.
2. Ensure the stability and integrity of nucleic acids.
3. Compared with the traditional twisted swab, the BioTeke "synthetic fiber flocking swab“ is to glue a large number of tiny nylon fibers to the top of a plastic rod, the efficiency of sample collection and release is 3 times higher than the traditional.
C.Disposable virus sampling swab kits
Specification | Inner Box Dimension | Boxers Per Carton | Carton Dimension | Cartons per Pallet |
100PET tubes+100swabs(10ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
50 kits(PET tube+swab)(10ml tube and 3ml liquid) | 20*17*18.5cm | 12 | 51*42*40cm | 18/24 |
100PET tubes+100swabs(5ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
50 kits(PET tube+swab)(5ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
100PP tubes+100 swabs(10ml tube and 3ml liquid) | 22.5*19*18cm | 12 | 58*52*38.5cm | 12/16 |
50 kits(PP tube+swab)(10ml tube and 3ml liquid) | 20*17*18.5cm | 12 | 52*42*40cm | 18/24 |
D.Disposable sampling swab
Specification | Dimension Overall length | Tip Diameter | Break point | Rod material | Tip Material |
Nasal swab 1 | 150±2mm | 5mm | 30±2mm | ABS | Flocked fabric |
Nasal swab 1 | 90±2mm | 2mm | 50±2mm | ABS | Flocked fabric |
Pharyngeal swab 1 | 150±2mm | 3mm | 80±2mm | ABS | Flocked fabric |
Pharyngeal swab 2 | 150±2mm | 3mm | 72±2mm | ABS | Flocked fabric |
Pharyngeal swab 3 | 150±2mm | 3mm | 66±2mm | ABS | Flocked fabric |
Universal swab 1 | 145±2mm | 3.5mm | 75±2mm | ABS | Flocked fabric |
Universal swab 2 | 152±2mm | 5.3mm | 80±2mm | ABS | Flocked fabric |
E.Comparison results
In general, the Ct value of Bioteke is lower than that of some common brands on the market, regardless of room temperature or 4℃ storage conditions.
The detection sensitivity is higher and the test results are more stable.
F.Product Qualification（by Dec.2nd,2022）
| Disposable Virus Sampling Swab Kits 一次性使用病毒采样管套装 | |
| FDA 510(k) premarket notification(ST9001-2) | FDA 510(k) 认证 (ST9001-2) |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明（采样管套装） |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明（采样管套装） |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明（样本保存液） |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明（样本保存液） |
| MHRA Registration | 英国 MHRA 注册 |
| MHRA Registration- UKCA Declaration of Conformity | 英国 MHRA 注册-UKCA 符合性声明 |
| FDA Registration | FDA 注册 |
| Australian Register of Therapeutic Goods Certificate | 澳大利亚注册 |
| Italy Registration | 意大利注册 |
| Brazil ANVISA Registration-ST7001 | 巴西注册-ST7001 |
| Brazil ANVISA Registration-ST8001 | 巴西注册-ST8001 |
| Brazil ANVISA Registration-ST9001 | 巴西注册-ST9001 |
| Saudi Arabia Registration | 沙特注册 |
| Malaysia Registration | 马来西亚注册 |
| Indonesia Registration | 印度尼西亚注册 |
| Botswana registration exemption | 博茨瓦纳注册豁免 |
| New Zealand registration | 新西兰注册 |
| Peru registration exemption | 秘鲁注册豁免 |
| CFDA(NMPA) Registration | CFDA(NMPA) 注册 |
| Certificate for Exportation of Medical Products | 出口销售证明 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free sale certificate-Saudi Arabia | 自由销售证明-沙特阿拉伯 |
| Free sale certificate-Malaysia | 自由销售证明-马来西亚 |
| Free sale certificate-Mexico | 自由销售证明-墨西哥 |
| Free sale certificate-Indonesia | 自由销售证明-印尼 |
| ISO 11737 Test Report | ISO 11737 测试报告 |
| REACH Test Report | REACH 测试报告 |
| EN11137 Test Report | EN11137 测试报告 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | ISO 14001环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
Warm Warning:This product is not available for US market.
A.Description
The sampling swab uses advanced jet implanted nylon fuzz technology. Compared with conventional fiber swabs, the sample is easily penetrated, diluted, and trapped in the fiber. The nylon flocking swab has outstanding sample collection and release capability, and the release rate can reach 90%, which is much higher than that of the conventional fiber swab.
Light red media formation contains antibiotics that can effectively inhibit the reproduction of bacteria and fungi.
B.Advantage&Features
1. Rapid preservation of viral nucleic acids.
2. Ensure the stability and integrity of nucleic acids.
3. Compared with the traditional twisted swab, the BioTeke "synthetic fiber flocking swab“ is to glue a large number of tiny nylon fibers to the top of a plastic rod, the efficiency of sample collection and release is 3 times higher than the traditional.
C.Disposable virus sampling swab kits
Specification | Inner Box Dimension | Boxers Per Carton | Carton Dimension | Cartons per Pallet |
100PET tubes+100swabs(10ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
50 kits(PET tube+swab)(10ml tube and 3ml liquid) | 20*17*18.5cm | 12 | 51*42*40cm | 18/24 |
100PET tubes+100swabs(5ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
50 kits(PET tube+swab)(5ml tube and 3ml liquid) | 20*16.5*15.5cm | 12 | 51*41*33cm | 24 |
100PP tubes+100 swabs(10ml tube and 3ml liquid) | 22.5*19*18cm | 12 | 58*52*38.5cm | 12/16 |
50 kits(PP tube+swab)(10ml tube and 3ml liquid) | 20*17*18.5cm | 12 | 52*42*40cm | 18/24 |
D.Disposable sampling swab
Specification | Dimension Overall length | Tip Diameter | Break point | Rod material | Tip Material |
Nasal swab 1 | 150±2mm | 5mm | 30±2mm | ABS | Flocked fabric |
Nasal swab 1 | 90±2mm | 2mm | 50±2mm | ABS | Flocked fabric |
Pharyngeal swab 1 | 150±2mm | 3mm | 80±2mm | ABS | Flocked fabric |
Pharyngeal swab 2 | 150±2mm | 3mm | 72±2mm | ABS | Flocked fabric |
Pharyngeal swab 3 | 150±2mm | 3mm | 66±2mm | ABS | Flocked fabric |
Universal swab 1 | 145±2mm | 3.5mm | 75±2mm | ABS | Flocked fabric |
Universal swab 2 | 152±2mm | 5.3mm | 80±2mm | ABS | Flocked fabric |
E.Comparison results
In general, the Ct value of Bioteke is lower than that of some common brands on the market, regardless of room temperature or 4℃ storage conditions.
The detection sensitivity is higher and the test results are more stable.
F.Product Qualification（by Dec.2nd,2022）
| Disposable Virus Sampling Swab Kits 一次性使用病毒采样管套装 | |
| FDA 510(k) premarket notification(ST9001-2) | FDA 510(k) 认证 (ST9001-2) |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明（采样管套装） |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明（采样管套装） |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明（样本保存液） |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明（样本保存液） |
| MHRA Registration | 英国 MHRA 注册 |
| MHRA Registration- UKCA Declaration of Conformity | 英国 MHRA 注册-UKCA 符合性声明 |
| FDA Registration | FDA 注册 |
| Australian Register of Therapeutic Goods Certificate | 澳大利亚注册 |
| Italy Registration | 意大利注册 |
| Brazil ANVISA Registration-ST7001 | 巴西注册-ST7001 |
| Brazil ANVISA Registration-ST8001 | 巴西注册-ST8001 |
| Brazil ANVISA Registration-ST9001 | 巴西注册-ST9001 |
| Saudi Arabia Registration | 沙特注册 |
| Malaysia Registration | 马来西亚注册 |
| Indonesia Registration | 印度尼西亚注册 |
| Botswana registration exemption | 博茨瓦纳注册豁免 |
| New Zealand registration | 新西兰注册 |
| Peru registration exemption | 秘鲁注册豁免 |
| CFDA(NMPA) Registration | CFDA(NMPA) 注册 |
| Certificate for Exportation of Medical Products | 出口销售证明 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free sale certificate-Saudi Arabia | 自由销售证明-沙特阿拉伯 |
| Free sale certificate-Malaysia | 自由销售证明-马来西亚 |
| Free sale certificate-Mexico | 自由销售证明-墨西哥 |
| Free sale certificate-Indonesia | 自由销售证明-印尼 |
| ISO 11737 Test Report | ISO 11737 测试报告 |
| REACH Test Report | REACH 测试报告 |
| EN11137 Test Report | EN11137 测试报告 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | ISO 14001环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
