EliA SmDP-S Well DECC056720

GUDID 07333066017709

EliA SmDP-S Well

Phadia AB

Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay
Primary Device ID07333066017709
NIH Device Record Key37931db5-1ddd-4e74-8ac1-b78985cab7aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameEliA SmDP-S Well
Version Model NumberDECC056720
Catalog NumberDECC056720
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
GS107333066017709 [Package]
Contains: 07333066021485
Package: [4 Units]
In Commercial Distribution
GS107333066021485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKPANTI-SM ANTIBODY, ANTIGEN AND CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-28
Device Publish Date2021-07-20

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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

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