11 results
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42ms
·
Sources: EU EUDAMED, US FDA
PCT Brahms Elecsys cobas e 100
FDA registration
ROCHE DIAGNOSTICS GMBH·3 products·🇩🇪 Germany
Elecsys BRAHMS PCT
FDA 510(k)
FDA Class 2
·Microbiology
Procalcitonin Assay
FDA classification
FDA Class 2
·Procalcitonin Assay
Isomedix Operations, Inc.
FDA registration
Isomedix Operations, Inc.·1 product·🇺🇸 United States
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
FDA registration
Medline ReNewal·2 products·🇺🇸 United States
Digitex Delivery Device
FDA registration
COLOPLAST MANUFACTURING US, LLC·1 product·🇺🇸 United States
APOLLO MR3T
FDA registration
LAP of America Laser Applications, LLC.·1 product·🇺🇸 United States
DIP/U.S. Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
FDA 510(k)
FDA Class 2
·Hematology
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
FDA classification
FDA Class 2
·Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Assay, Glycosylated Hemoglobin
FDA classification
FDA Class 2
·Assay, Glycosylated Hemoglobin