EliA anti-TPO Well DECC056410

GUDID 07333066015040

EliA anti-TPO Well

Phadia AB

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, fluorescent immunoassay
Primary Device ID07333066015040
NIH Device Record Key511388b1-dd40-4625-94b5-8f138a2c57ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameEliA anti-TPO Well
Version Model NumberDECC056410
Catalog NumberDECC056410
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066015040 [Package]
Contains: 07333066015729
Package: [4 Units]
In Commercial Distribution
GS107333066015729 [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

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