FDA.reportPublic FDA data

Phadia 2500E

Primary DI
07333066020921
Brand
Phadia 2500E
Company
Phadia AB
Model
12-4100-01
Catalog number
12-4100-01
Device description
Phadia 2500E
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHXANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061165000ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01Sweden Diagnostics (Us), Inc.2006-08-03NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066020921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066020921073330660209217333066020921

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29
07333066024240EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024271EliA IgM Calibrator WellDECC066270DECC0662702026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066015798EliA CCP WellPhadia ABNHX2026-01-29
07333066024202EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066024226EliA Dummy WellPhadia ABNHX2026-01-29
07333066015507EliA CCP WellPhadia ABNHX2026-01-29
07333066023908EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066023939EliA Dummy WellPhadia ABNHX2026-01-29
07333066020907Phadia 5000EPhadia ABNHX2020-12-01
07333066020914Phadia 5000E+EPhadia ABNHX2020-12-01
07333066020938Phadia 2500EEPhadia ABNHX2020-12-01
03610522053131BioPlex 2200BIO-RAD LABORATORIES, INC.NHX2019-11-27
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAAXIS-SHIELD DIAGNOSTICS LIMITEDNHX2019-08-02
07333066020020EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066014173EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066020051EliA IgG CalibratorsPhadia ABNHX2019-03-26
07333066001036Dilution Plate, Phadia 250Phadia ABNHX2019-02-20
00380740151362AlinityAbbott GmbHNHX2018-12-04
00630414245669Atellica IM aCCPSiemens Healthcare Diagnostics Inc.NHX2018-10-19
04049016026853Anti-CCP ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNHX2016-09-24
00630414592312ADVIA Centaur® aCCP IgGSiemens Healthcare Diagnostics Inc.NHX2016-09-24
00630414601991IMMULITE® 2000 Systems CCP Anti-CCP IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNHX2016-09-24
07333066012629EliA IgG ConjugatePhadia ABNHX2016-09-23
07333066012636EliA Sample DiluentPhadia ABNHX2016-09-23
07333066012704EliA IgG Curve ControlPhadia ABNHX2016-09-23
07333066012797EliA IgG Calibrator StripPhadia ABNHX2016-09-23
07333066012803EliA IgG Curve Control StripPhadia ABNHX2016-09-23
07333066012810EliA IgG Conjugate 50Phadia ABNHX2016-09-23
07333066012827EliA IgG Conjugate 200Phadia ABNHX2016-09-23
07333066012872EliA Sample DiluentPhadia ABNHX2016-09-23
07333066013015EliA CCP Positive Control 250Phadia ABNHX2016-09-23
07333066013060EliA CCP Positive Control 100Phadia ABNHX2016-09-23