EliA IgG Calibrator Well DECC066090

GUDID 07333066023908

EliA IgG Calibrator Well

Phadia AB

Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07333066023908
NIH Device Record Key28d92410-05d3-4981-b9ae-4b6876ab4133
Commercial Distribution StatusIn Commercial Distribution
Brand NameEliA IgG Calibrator Well
Version Model NumberDECC066090
Catalog NumberDECC066090
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107333066023908 [Package]
Contains: 07333066024202
Package: [4 Units]
In Commercial Distribution
GS107333066024202 [Primary]

FDA Product Code

NHXANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-06
Device Publish Date2026-01-29

On-Brand Devices [EliA IgG Calibrator Well]

07333066010649EliA IgG Calibrator Well
07333066023908EliA IgG Calibrator Well

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