Global Quality Excellence

Global Quality Excellence: Our Commitment to Compliance and Innovation

Quality Assurance Policy
Good Biotech Corp. upholds a rigorous Quality Assurance (QA) program to ensure the safety, efficacy, and reliability of our diagnostic and life science products. Our policy integrates international regulatory standards with a culture of accountability, driving excellence in every aspect of our operations.

  1. Excellence in Product Delivery
    We deliver high-quality solutions worldwide by adhering to strict internal procedures and empowering every employee to prioritize quality in production, service, and innovation.
  2. Global Regulatory Compliance
    Our products meet internationally recognized standards, including ISO guidelines, IVD GMP requirements, and EU TRACES Certification.
  3. Robust Quality Management System
    Our harmonized Quality Management System (QMS) ensures consistent compliance with global regulatory requirements, streamlining processes from development to delivery while maintaining operational integrity.
  4. Employee Accountability
    Quality is embedded in our corporate culture through mandatory training, clearly documented protocols, and cross-departmental responsibility for compliance outcomes.

Certifications

FDA 510(k) clearance

CE Marking

TRACES Approval Facility

 

 

510(k) Number & Device Name by Good Biotech Corp.

510(k) Number

K020603

Device Name

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

510(k) Number

K050576

Device Name

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

510(k) Number

K050713

Device Name

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

510(k) Number

K021757

Device Name

CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

510(k) Number

K052617

Device Name

FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,

510(k) Number

K063766

Device Name

TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C

510(k) Number

K021882

Device Name

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

510(k) Number

K022725

Device Name

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013