FDA.reportPublic FDA data

ImmunoCAP IgE/ECP/Tryptase Sample Diluent

Primary DI
07333066000336
Brand
ImmunoCAP IgE/ECP/Tryptase Sample Diluent
Company
Phadia AB
Model
34-2275-01
Catalog number
34-2275-01
Device description
ImmunoCAP IgE/ECP/Tryptase Sample Diluent
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DGCIGE, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DGCIge, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133404000IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMHPhadia AB2014-02-24DGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066000336PackageGS11In Commercial Distribution
07333066011660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066000336073330660003367333066000336
07333066011660073330660116607333066011660

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of plasma proteins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00816870024400IgE-XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2024-09-13
00850054026477QMedix™Diagnostic Automation, Inc.DGC2024-01-31
00380740153700AlinityABBOTT LABORATORIESDGC2023-10-14
04048474017885Immunoglobulin E (IgE) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDGC2023-08-26
15099590701727Total Immunoglobulin E (IgE)Beckman Coulter, Inc.DGC2022-05-03
00840239017888Immunoglobulin E (IgE) ELISADRG International IncDGC2021-06-07
00380740156282ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156367ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156404ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00850392007350BioCheck IgE EIA Test KitBIOCHECK, INC.DGC2019-10-08
07333066019864ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066000664ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066019772ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066019789ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066019796ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066000206ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066000220ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066000367ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066019512ImmunoCAP Total IgE CalibratorsPhadia ABDGC2019-03-26
07333066019529ImmunoCAP Total IgE Curve ControlsPhadia ABDGC2019-03-26
07333066019642ImmunoCAP Total IgE Control LMHPhadia ABDGC2019-03-26
07333066019673ImmunoCAP Total IgEPhadia ABDGC2019-03-26
00816870020242IgE AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870020259Monobind AccuBind IgE ELISA Kit - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870020266IgE AccuBind ELISA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870020273IgE AccuBind ELISA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11
00816870021928Monobind AccuLite IgE CLIA Kit - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870021935IgE AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870021942IgE AccuLite CLIA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870021959IgE AccuLite CLIA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11