EliA Celiac Positive Control 2500/5000 83-0008-91

GUDID 07333066014180

EliA Celiac Positive Control 2500/5000

Phadia AB

Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control Plasma protein IVD, control
Primary Device ID07333066014180
NIH Device Record Keyd47bacab-eda0-4de8-b7f4-19c9d1034278
Commercial Distribution StatusIn Commercial Distribution
Brand NameEliA Celiac Positive Control 2500/5000
Version Model Number83-0008-91
Catalog Number83-0008-91
Company DUNS354019424
Company NamePhadia AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx
Phone+469999999999
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066013176 [Primary]
GS107333066014180 [Package]
Contains: 07333066013176
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)
MVMAutoantibodies, endomysial(tissue transglutaminase)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-17
Device Publish Date2020-12-09

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07333066021706 - ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed2022-12-01 ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
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