ImmunoCAP Allergen e73, Rat epithelium 14-4396-01

GUDID 07333066003672

ImmunoCAP Allergen e73, Rat epithelium

Phadia AB

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07333066003672
NIH Device Record Keyecb9f132-01e7-450f-8ec9-2347fd270f08
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCAP Allergen e73, Rat epithelium
Version Model Number14-4396-01
Catalog Number14-4396-01
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 Usefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066003672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHBSYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Phadia AB

07333066021621 - Phadia 2500+ LAS Connector2023-11-28 Phadia 2500+ LAS Connector
07333066003023 - ImmunoCAP Dummy ImmunoCAP2023-07-18 ImmunoCAP Dummy ImmunoCAP
07333066005454 - ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat2022-12-01 ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat
07333066010922 - ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat2022-12-01 ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat
07333066010991 - ImmunoCAP Allergen f98, Gliadin2022-12-01 ImmunoCAP Allergen f98, Gliadin
07333066021706 - ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed2022-12-01 ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
07333066014876 - EliA Ro60 Well2022-09-22 EliA Ro60 Well
07333066014906 - EliA Ro52 Well2022-09-22 EliA Ro52 Well

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.