Log In

Part Description

LP248456-8   Blanket no changes certification of product listing
A blanket 'no changes' certification covers all listed drug products for which listing information has previously been submitted electronically and no listing information has changed since the previous update. https://www.federalregister.gov/documents/2016/08/31/2016-20471/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs#p-822 Source: Regenstrief LOINC

LOINC Names Get Info

Fully-Specified Name
Blanket no changes certification of product listing:-:-:^FDA package insert:Nar:
Long Common Name
FDA package insert Blanket no changes certification of product listing
Short Name
FDA insert Blnkt no chngs cert prod list

Part Model Get Info

  • Component
    Blanket no changes certification of product listing
    LP248456-8
    • Analyte
      Blanket no changes certification of product listing
      LP248456-8
      • Component Numerator
        Blanket no changes certification of product listing
        LP248456-8
        • Component Numerator Core
          Blanket no changes certification of product listing
          LP248456-8
        • Component Numerator Core Suffix
          NULL
           
      • Component Denominator
        NULL
         
        • Component Denominator Core
          NULL
           
        • Component Denominator Core Suffix
          NULL
           
    • Challenge
      NULL
       
    • Adjustment
      NULL
       
    • Count
      NULL
       
  • Property
    -
    LP6769-6
  • Time
    -
    LP70420-2
  • System
    ^FDA package insert
    LP281754-4
    • System Core
      NULL
       
    • Super System
      FDA package insert
      LP36024-5
  • Scale
    Nar
    LP7749-7
  • Method
    NULL
     

Basic Attributes

Class
DOCUMENT.REGULATORY
Type
Clinical
First Released
Version 2.61
Last Updated
Version 2.61 (ADD)
Order vs. Observation
Both

Language Variants Get Info

TagLanguageTranslation
el-GRGreek (Greece)Ολοκληρωμένη πιστοποίηση καταχώρισης προϊόντων χωρίς αλλαγές:-:-:^Ένθετο συσκευασίας FDA:Nar:
Synonyms: - DOCUMENT.REGULATORY Nar Ένθετο συσκευασίας FDA Ολοκληρωμένη πιστοποίηση καταχώρισης προϊόντων χωρίς αλλαγές Πιστοποίηση
es-MXSpanish (Mexico)Certificación general sin cambios de la lista de productos:-:-:^ Prospecto de la FDA:Narrativo:
it-ITItalian (Italy)Certificazione generale senza cambiamenti di una lista di prodotti:-:-:^FDA, foglio illustrativo:Nar:
Synonyms: Documentazione normativa Foglio illustrativo della Food and Drug Administra
zh-CNChinese (China)关于产品列名的综合式无变更证书:-:-:^FDA 包装说明书:叙述型:
Synonyms: SPL;结构化产品标签;结构化产品标签;Structured Product Labelling;结构化产品标记;结构化产品标识;美国食品及药品管理局包装说明书;超系统 - FDA 包装说明书;食品及药品管理局包装说明书;FDA 包装插页 关于产品列名（产品提列、产品清单、产品列表）的综合式（总括式）无变更证书 叙述;叙述性文字;报告;报告型;文字叙述;文本叙述型;文本描述;文本描述型 监管类文档 认证（检定、证明、鉴定、发证、出具课程结业证书、确认）;医疗认证级别（等级、水平）;medical certification level

LOINC Terminology Service (API) using HL7® FHIR® Get Info

CodeSystem lookup
https://fhir.loinc.org/CodeSystem/$lookup?system=http://loinc.org&code=86445-4