Establishment Registration & Device Listing | 合法醫療器材資訊網
ProprietaryName:ElecsysHSV-1IgG;ELECSYSHSV-1IGGIMMUNOASSAYELECSYSPRECICONTROLHSV;HSVPCElecsys;HSV-1IgGElecsyscobase ...
References MXJ (www.accessdata.fda.gov) 866.3305 (www.accessdata.fda.gov) ROCHE DIAGNOSTICS GMBH (www.accessdata.fda.gov) K120625 (www.accessdata.fda.gov) Roche Diagnostics Operations Inc. (www.accessdata.fda.gov) Proprietary Name: Elecsys HSV-1 IgG; ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV; HSV PC Elecsys; HSV-1 IgG Elecsys cobas e 100; HSV-1 IgG Elecsys E2G 100 Classification Name: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 Product Code: MXJ[1] Device Class: 2 Regulation Number: 866.330...
roche hsv assay roche hsv assay 萊克多巴胺 瀚揚有限公司ptt 瀚揚國際凱茲 Tuffy 玩具 “Clariance” Idys-LIF cages Alinity Abbott Siemens Coat-A-Count Ferritin IRMA On Call Plus
510(k) Premarket Notification | 合法醫療器材資訊網
... herpes simplex virus, hsv-122. 510(k) Number, K120625. Device Name, ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV. Applicant ... Read More
510(k) Summary | 合法醫療器材資訊網
2012年6月29日 — (2) Elecsys PreciControl HSV contains lyophilized control serum based on ... The Elecsys HSV-2 IgG immunassay test system is substantially. Read More
510(k) Summary JUL2521 | 合法醫療器材資訊網
(2) PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the. Elecsys HSV-lI IgG ... Read More
Elecsys Precicontrol HSV 12 IgG | 合法醫療器材資訊網
Elecsys Precicontrol HSV 1 and 2 IgG (2x2x3 mL). Control dedicated to Roche Elecsys, E411, E601, E602, E801, and Modular to control the functioning of HSV ... Read More
Elecsys® HSV | 合法醫療器材資訊網
Elecsys® HSV-1 IgG. Immunoassay for the qualitative determination of IgG-antibodies to Herpes Simplex Virus type 1. Read More
Establishment Registration & Device Listing | 合法醫療器材資訊網
Proprietary Name: Elecsys HSV-1 IgG; ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV; HSV PC Elecsys; HSV-1 IgG Elecsys cobas e ... Read More
K120625 B. Purpose for Submission | 合法醫療器材資訊網
由 C Measurand 著作 — PreciControl HSV is used for quality control of the Elecsys HSV-1 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers. 2. Indication(s) for use:. Read More
K120625 ELECSYS HSV | 合法醫療器材資訊網
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV,Roche Diagnostics,Product Code: MXJ. Read More
PreciControl HSV - Ms - 05572207190.v3.en | 合法醫療器材資訊網
PreciControl HSV is used for quality control of the Elecsys HSV1IgG and. Elecsys HSV2IgG immunoassays on the Elecsys and cobase However, as no testing ... Read More
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