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Phone Number : +86 13989889852

WhatsApp : +008613989889852

QC Profile

AllTest has a well-established quality system, which meets the requirements of the international quality standards ISO 13485.US FDA and cGMP.

AllTest products are CE certified and in conformity with the essential requirements and procedures of the European Council Directive 98/79/EC on medical devices.

As we all know, quality is only way to win customer trust and Preference.
We are committed to offering products and services to our customers that meet their needs with sound quality.

Quality is everybody’s commitment. Our management takes the lead to set objectives and demonstrates its commitment towards quality by practicing and living what they preach. All AllTEST functions are fully responsible for observing mandatory principles, norms and instructions for maintaining agreed quality standards and for constantly improving them. Our quality personnel at all levels are the guardians of quality. They promote quality awareness, assess performance and challenge the organization to sustain and improve quality standards.


 

  • Hangzhou AllTest Biotech CO.,LTD
    Standard: GMP
    Number: 00049937
    Issue Date: 2022-10-08
    Expiry Date: 2023-03-19
    Scope/Range:
    Issued By: Zhejiang Province Food and Drug Administration
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: Australia TGA
    Number: DV-2019-MC-01440-1
    Issue Date: 2021-06-08
    Expiry Date:
    Scope/Range:
    Issued By: Australian Register of Therapeutic Goods
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: HCG PREGNANCY LICENCE
    Number: 97429
    Issue Date: 2016-08-03
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: LH OVULATION LICENCE
    Number: 97431
    Issue Date: 2016-08-03
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: CE Certificate
    Number: V109123008 Rev.04
    Issue Date: 2022-04-05
    Expiry Date: 2025-05-26
    Scope/Range:
    Issued By: TUV
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: CE Certificate
    Number: V109123008 Rev.04
    Issue Date: 2022-04-05
    Expiry Date: 2025-05-26
    Scope/Range:
    Issued By: TUV
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: ISO13485 :2016
    Number: Q5 095123 0007 Rev.03
    Issue Date: 2020-09-25
    Expiry Date: 2023-09-24
    Scope/Range:
    Issued By: TUV
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: URINALYSIS LICENCE
    Number: 97757
    Issue Date: 2016-09-26
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: HCG PREGNANCY LICENCE
    Number: 98910
    Issue Date: 2017-03-31
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: H.pylori Antigen Licence
    Number: 99054
    Issue Date: 2017-04-26
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: RSV LICENCE
    Number: 99055
    Issue Date: 2017-04-26
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: INFLUENZA A+B LICENCE
    Number: 99135
    Issue Date: 2017-05-10
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: CE Certificate
    Number: SH221064A02
    Issue Date: 2022-04-05
    Expiry Date: 2025-05-26
    Scope/Range:
    Issued By: TUV
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MONO LICENCE
    Number: 99684
    Issue Date: 2017-09-19
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: HCG PREGNANCY LICENCE
    Number: 99718
    Issue Date: 2017-09-22
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: FYL CASSETTE LICENSE
    Number: 102076
    Issue Date: 2018-11-21
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MALARIA P.F./PAN LICENSE
    Number: 102077
    Issue Date: 2018-11-21
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MALARIA P.F./P.V LICENSE
    Number: 102078
    Issue Date: 2018-11-21
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: FYL DIPSTICK LICENSE
    Number: 102080
    Issue Date: 2018-11-21
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MDSAP
    Number: QS60951230009 Rev.01
    Issue Date: 2022-01-21
    Expiry Date: 2025-01-06
    Scope/Range:
    Issued By: TUV
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: U.S.FOOD&DRUG
    Number: K182738
    Issue Date: 2019-02-19
    Expiry Date:
    Scope/Range:
    Issued By: FDA
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MULTI-DRUG LICENSE
    Number: 102536
    Issue Date: 2019-12-06
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: D-DIMER LICENSE
    Number: 102657
    Issue Date: 2019-04-01
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: PCT LICENSE
    Number: 102660
    Issue Date: 2019-04-01
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: VITAMIN D LICENSE
    Number: 102661
    Issue Date: 2022-06-21
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: MYCOPLASMA PNEUMONIAE LICENSE
    Number: 102662
    Issue Date: 2019-04-01
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: LEPTOSPIRA IGG&IGM LICENSE
    Number: 102680
    Issue Date: 2019-04-03
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: ACE5000 LICENSE
    Number: 102743
    Issue Date: 2019-04-15
    Expiry Date:
    Scope/Range:
    Issued By: CANADA HEALTH
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: ISO9001
    Number: QMS/91/R/2292/b
    Issue Date: 2017-04-24
    Expiry Date: 2023-04-23
    Scope/Range:
    Issued By: Zenith Quality Assessors
  • Hangzhou AllTest Biotech CO.,LTD
    Standard: CE Certificate
    Number: CeCert/088/W*E
    Issue Date: 2022-05-11
    Expiry Date: 2025-05-26
    Scope/Range:
    Issued By: IVD Medical Device