Class 3 Device Recall VITROS Immunodiagnostic HBsAg ... | 合法醫療器材資訊網
2016年10月25日—TheperformanceoftheVITROSImmunodiagnosticProductsHBsAgControlshasnotbeenestablishedwithanyotherHBsAgassay.
References Related Medical Device Recalls (www.accessdata.fda.gov) K030067 (www.accessdata.fda.gov) Kit, serological, positive control (www.accessdata.fda.gov) MJX (www.accessdata.fda.gov) TPLC Device Report (www.accessdata.fda.gov) medical device recalls (www.fda.gov) Code of Federal Regulations (CFR) Title 21 §7.55 (www.accessdata.fda.gov) 510(K)s with Product Code = MJX and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS (www.accessdata.fda.gov) Date Initiated by Firm June 22, 2016 Create Date ...
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Premarket Approval (PMA) | 合法醫療器材資訊網
THE VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ... Read More
Class 3 Device Recall VITROS Immunodiagnostic HBsAg ... | 合法醫療器材資訊網
2016年10月25日 — The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay. Read More
MAUDE Adverse Event Report: ORTHO | 合法醫療器材資訊網
The investigation determined (b)(6) vitros hbsag results for patient samples processed using vitros immunodiagnostic products hbsag reagent on a vitros 3600 ... Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK IN VITRO ... Read More
INSTRUCTIONS FOR USE HBsAg | 合法醫療器材資訊網
The VITROS HBsAg assay is performed using the VITROS HBsAg Reagent Pack and VITROS Immunodiagnostic Products. HBsAg Calibrator on the VITROS ECi/ ... Read More
INSTRUCTIONS FOR USE HBCon | 合法醫療器材資訊網
HBsAg Reagent Pack and the VITROS Immunodiagnostic Products HBsAg Calibrator with the VITROS ECi/ECiQ. Immunodiagnostic System. WARNING:. Read More
Hepatitis B Surface Antigen (HBsAg) | 合法醫療器材資訊網
The VITROS HBsAg test is performed using the VITROS HBsAg Reagent Pack and. VITROS Immunodiagnostic Products HBsAg Calibrator on the VITROS ECi/ ... Read More
Hepatitis B Surface Antibody (anti | 合法醫療器材資訊網
1. Laboratory Procedure Manual. Analyte: Hepatitis B Surface Antibody (anti-HBS). Matrix: Serum. Method: aHBs-Anti-HBs. VITROS Immunodiagnostic Products. Read More
VITROS Immunodiagnostic Products HBsAg Calibrator ... | 合法醫療器材資訊網
VITROS Immunodiagnostic Products HBsAg Calibrator. ORTHO CLINICAL ... 10758750002788, VITROS Immunodiagnostic Products Anti-HBs Reagent Pack. Read More
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