ImmunoCAP Specific IgE Control L 34-2341-11

GUDID 07333066000930

ImmunoCAP Specific IgE Control L

Phadia AB

Plasma protein IVD, control
Primary Device ID07333066000930
NIH Device Record Key88faccf7-d1ea-46a8-902f-474f1b75da7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCAP Specific IgE Control L
Version Model Number34-2341-11
Catalog Number34-2341-11
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
GS107333066000930 [Package]
Contains: 07333066019949
Package: [6 Units]
In Commercial Distribution
GS107333066019949 [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 Date2019-04-08
Device Publish Date2019-03-29

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07333066024035 - EliA IgM Calibrator Well2026-02-06 EliA IgM Calibrator Well
07333066024110 - EliA RF IgM Well2026-02-06 EliA RF IgM Well
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