1.
Fed Regist
; 82(218): 52647-9, 2017 Nov 14.
Artigo
em Inglês
| MEDLINE
| ID: mdl-29231688
RESUMO
The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software-assisted system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated indirect immunofluorescence microscope and software-assisted system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Assuntos
Técnica Indireta de Fluorescência para Anticorpo/classificação , Técnica Indireta de Fluorescência para Anticorpo/instrumentação , Microscopia/classificação , Microscopia/instrumentação , Software/classificação , Processamento Eletrônico de Dados , Humanos
2.
Rev. Inst. Med. Trop. Säo Paulo
; 40(5): 329-31, Sept.-Oct. 1998. tab
Artigo
em Inglês
| LILACS
| ID: lil-225859