Establishment Registration & Device Listing | 合法醫療器材資訊網
myoglobin,antigen,antiserum,control-AlinityiSTATMyoglobinReagentKit...chemistry(photometric,discrete),forclinicaluse-AbbottARCHITECTSystem; ...
References test, hepatitis b (b core, be antigen, be antibody, b core igm) - Alinity i Anti-HBs Calibrators (LN 07P8801); Alinity i Anti-HBs Controls (LN 07P8810); Alinity i Anti-HBs Reagent Kit (LN 07P8851, 07P8856); Alinity i Anti-HBs Reagent Kit (LN 07P8852, 07P8857); Alinity i Anti-HBs Specimen Diluent (LN 07P8841); ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03); ARCHITECT AUSAB Controls (LN 1L82-12, 1L82-13); ARCHITECT AUSAB Reagent Kit (LN 1L82-25, 1L82-35, 1L82-26, 1L82-27, 1L82-36, 1L82-37); ARCHITECT AUSAB Reagent Kit (LN 1L82-28, 1L82-38); ARCHITECT AUSAB Specimen Diluent (LN 1L82-40) (www.accessdata.fda.gov) nadh oxidation/nad reduction, alt/sgpt - Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824); ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42); A...
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1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
The ARCHITECT® STAT Myoglobin Calibrators are for calibration of the ... calibrators and controls (controls have been cleared k040880). ... Abbott AxSYM. ®. Read More
ARCHITECT STAT Myoglobin Reagent Kit ... | 合法醫療器材資訊網
ARCHITECT STAT Myoglobin Reagent Kit – ARCHITECT i1000SR. ... balenie: 6 x 4 ml, 2K4301, – €. ARCHITECT Myoglobin Controls balenie: 6 x 3 ml, 2K4310 ... Read More
ARCHITECT STAT Myoglobin Reagent Kit 100t ... | 合法醫療器材資訊網
ARCHITECT STAT Myoglobin Reagent Kit 100t – ARCHITECT i1000SR. ... x 4 ml, 2K4301, – Kč. ARCHITECT Myoglobin Controls balení: 6 x 3 ml, 2K4310, – Kč ... Read More
Establishment Registration & Device Listing | 合法醫療器材資訊網
myoglobin, antigen, antiserum, control - Alinity i STAT Myoglobin Reagent Kit ... chemistry (photometric, discrete), for clinical use - Abbott ARCHITECT System; ... Read More
MYOGLOBIN | 合法醫療器材資訊網
For further information, refer to the AxSYM System Operations Manual,. Section 3. REAGENTS. REAGENT PACK, 100 TESTS. AxSYM Myoglobin Reagent Pack ( ... Read More
September 13 | 合法醫療器材資訊網
2019年9月13日 — Trade/Device Name: ARCHITECT STAT High Sensitivity Troponin-I ... controls provisions of the Act. Although this letter refers to your product as ... Read More
STAT Myoglobin | 合法醫療器材資訊網
International: Call your Abbott Representative. This package insert ... For diagnostic purposes, the ARCHITECT STAT Myoglobin assay results should be used in ... Read More
STAT Troponin | 合法醫療器材資訊網
2010年3月9日 — ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) ... available biomarkers of necrosis, including CK-MB, myoglobin, lactate dehydrogenase, and ... ARCHITECT System Operations Manual, Section 3. i. * = immunoassa Read More
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