EliA anti-TG Well DECC056420

GUDID 07333066015057

EliA anti-TG Well

Phadia AB

Thyroglobulin antibody IVD, kit, fluorescent immunoassay
Primary Device ID07333066015057
NIH Device Record Keyab98f9c3-9898-454d-b218-19edc1d2c6d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEliA anti-TG Well
Version Model NumberDECC056420
Catalog NumberDECC056420
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066015057 [Package]
Contains: 07333066015736
Package: [4 Units]
In Commercial Distribution
GS107333066015736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JZOSYSTEM, TEST, THYROID AUTOANTIBODY

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.