Quality Control

Quality Assurance Policy

Good Biotech Corp. has developed an extensive internal Quality Assurance program to ensure quality, safety, reliability and effectiveness of all our products. Good Biotech is determined to provide the qualified products and services to worldwide customers as a diagnostics and life science products manufacturer. We provide services in accordance with International Organization for Standardization (ISO) and our diagnostic products are FDA (510)k ClearedCE Marked and IVD GMP approval. In meeting the requirements of these harmonized standards, the company demonstrated that it has a conforming Quality System in place, with processes that are consistently executed in daily operations. We have commitment to our international markets through the global harmonization of regulatory compliance requirement and all the employees of Good Biotech Corp. are fully committed to the company procedures and policies. Company quality management policy is documented, practiced and maintained by each employee at Good Biotech.

 

Certifications

FDA 510(k) clearance CE Marking

 

 

 

 

 

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