510(k) Premarket Notification | 合法醫療器材資訊網
vitrosimmunodiagnosticproductsanemiacontrols33,Ortho-ClinicalDiagnostics,Inc.K99001634,05/19/1999.vitrosimmunodiagnosticproductsca125ii ...
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
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510(k) Premarket Notification | 合法醫療器材資訊網
vitros immunodiagnostic products anemia controls33, Ortho-Clinical Diagnostics, Inc. K99001634, 05/19/1999. vitros immunodiagnostic products ca 125 ii ... Read More
K973331.pdf | 合法醫療器材資訊網
VitrosTM Immunodiagnostic Products Ferritin Reagent Pack (GEM. 1340) ... Vitrost Immunodiagnostic Products Ferritin Controls (GEM.5045) ... VITROS Immunodiagnostic Products Ferritin Calibrators ... overload) and iron deficiency anemia. Read More
Ortho | 合法醫療器材資訊網
This product cannot be ordered online due to special handling requirements. Please contact National Order Desk customer service at CS. Read More
SDS | 合法醫療器材資訊網
2015年6月1日 — GHS product identifier. Product Name. VITROS Immunodiagnostic Products Anaemia Controls. Other means of identification. Product Code(s). Read More
Technical Documents | 合法醫療器材資訊網
... Specifications, Control Assay Sheets, Maintenance Logs, and more for Ortho Clinical ... Chemistry & Immunodiagnostics ... VITROS® Immunodiagnostic Systems ... Order Fulfilment for Ortho Clinical Diagnostics Donor Screening Products ... Read More
VITROS Immunodiagnostic Products Anaemia Controls MSDS ... | 合法醫療器材資訊網
Product Name: VITROS Immunodiagnostic Products Anaemia Controls Product Code: OCDUK1619360 Language: English Regulation: GHS/CLP Manufacturer: ... Read More
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA ... | 合法醫療器材資訊網
multi-analyte controls, all kinds (assayed). 510(k) Number, K990016. Device Name, VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS. Read More
VITROS Immunodiagnostic Products RE Controls Medical ... | 合法醫療器材資訊網
VITROS 1009406. GUDID 10758750008322. VITROS Immunodiagnostic Products RE Controls. ORTHO CLINICAL DIAGNOSTICS. FDA.report; ›; GUDID ... Read More
VITROS® Assay Menu | 合法醫療器材資訊網
**Product availability is subject to fulfillment of regulatory requirements in each market. VITROS® HIV Combo Test. It's never too early to know. Your patients ... Read More
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