Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.
Fed Regist
; 72(21): 4637-8, 2007 Feb 01.
Article
em En
| MEDLINE
| ID: mdl-17294564
ABSTRACT
The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Manejo de Espécimes
/
Criopreservação
/
Separação Celular
/
Sangue Fetal
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Fed Regist
Ano de publicação:
2007
Tipo de documento:
Article