Development Solution 34-2247-36

GUDID 07333066000640

Development Solution

Phadia AB

Plasma protein IVD, reagent
Primary Device ID07333066000640
NIH Device Record Key12dc6471-b29d-4848-b5ee-30773eb02e6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDevelopment Solution
Version Model Number34-2247-36
Catalog Number34-2247-36
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

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze!

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066000640 [Package]
Contains: 07333066019703
Package: [6 Units]
In Commercial Distribution
GS107333066019703 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

On-Brand Devices [Development Solution]

07333066011097Development Solution
07333066000176Development Solution
07333066000640Development Solution
07333066000442Development Solution
07333066000435Development Solution

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