85480-2
FDA product label Establishment registration exempt notification
Active
Part Description
LP247992-3 Establishment registration exempt notification
Establishments that process blood products are regulated by the FDA need to register with FDA. The information in the blood establishment registration electronic file includes the address, contact information, and types of blood processed at the establishment. FDA will use that information for various purposes including for inspectors when they visit the site. For sites that do not require to register with the FDA, an exemption notification will be sent to the FDA from the establishment.
Source: Regenstrief LOINC
Fully-Specified Name
- Component
- Establishment registration exempt notification
- Property
- -
- Time
- -
- System
- ^FDA product label
- Scale
- Nar
- Method
Additional Names
- Short Name
- FDA label Est exmpt notif
Basic Attributes
- Class
- DOCUMENT.REGULATORY
- Type
- Clinical
- First Released
- Version 2.61
- Last Updated
- Version 2.61
- Order vs. Observation
- Both
Language Variants Get Info
Tag | Language | Translation |
---|---|---|
es-MX | Spanish (Mexico) | Notificación de exención de registro de establecimiento: |
it-IT | Italian (Italy) | Notifica di esenzione dalla registrazione dello stabilimento: Synonyms: Documentazione normativa Etichetta di prodotto della Food and Drug Administ |
zh-CN | Chinese (China) | 企业注册豁免通知: Synonyms: FDA 药品标签 企业(机构、 |
LOINC Terminology Service (API) using HL7® FHIR® Get Info
Requests to this service require a free LOINC username and password. Below is a sample of the possible capabilities. See the LOINC Terminology Service documentation for more information.
- CodeSystem lookup
- https:
//fhir.loinc.org/CodeSystem/$lookup?system=http: //loinc.org&code=85480-2
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