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 Cleared、CE Marked and the company is IVD GMP approval & a TRACES (Trade Control and Export System) approval facility. 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
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FDA 510(k) clearance 
CE Marking
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510(k) Number & Device Name by Good Biotech Corp. |
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510(k) Number |
K020603 |
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Device Name |
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 |
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510(k) Number |
K050576 |
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Device Name |
MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H |
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510(k) Number |
K050713 |
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Device Name |
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 |
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510(k) Number |
K021757 |
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Device Name |
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET |
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510(k) Number |
K052617 |
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Device Name |
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, |
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510(k) Number |
K063766 |
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Device Name |
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C |
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510(k) Number |
K021882 |
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Device Name |
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 |
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510(k) Number |
K022725 |
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Device Name |
CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 |
