FDA.reportPublic FDA data

ImmunoCAP Tryptase Calibrator Strip

Primary DI
07333066012544
Brand
ImmunoCAP Tryptase Calibrator Strip
Company
Phadia AB
Model
34-2342-21
Catalog number
34-2342-21
Device description
ImmunoCAP Tryptase Calibrator Strip
Published
2018-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYLTryptase assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYLTryptase Assay SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173704000ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripPhadia AB2018-03-02OYL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066000862PackageGS11In Commercial Distribution
07333066012544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066000862073330660008627333066000862
07333066012544073330660125447333066012544

GMDN Terms#

Term, Definition table
TermDefinition
Mast cell protease IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of a mast cell protease (e.g., tryptase, chymase), using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
354019424
Device count
1
Lot or batch
true
Expiration date on label
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
07333066019833ImmunoCAP Tryptase ControlPhadia ABOYL2019-03-28
07333066000350ImmunoCAP Tryptase ControlPhadia ABOYL2019-03-28
07333066011998ImmunoCAP Tryptase Curve Control 1Phadia ABOYL2019-02-15
07333066000275ImmunoCAP Tryptase Curve Control 1Phadia ABOYL2019-02-15
07333066012025ImmunoCAP Tryptase Conjugate 50Phadia ABOYL2018-10-01
07333066012551ImmunoCAP Tryptase Curve Control StripPhadia ABOYL2018-10-01
07333066012568ImmunoCAP Tryptase Curve Control 1Phadia ABOYL2018-10-01
07333066000893ImmunoCAP TryptasePhadia ABOYL2018-10-01
07333066000909ImmunoCAP Tryptase CalibratorsPhadia ABOYL2018-10-01
07333066000855ImmunoCAP Tryptase Conjugate 50Phadia ABOYL2018-10-01
07333066000862ImmunoCAP Tryptase Calibrator StripPhadia ABOYL2018-10-01
07333066000879ImmunoCAP Tryptase Curve Control StripPhadia ABOYL2018-10-01
07333066000916ImmunoCAP Tryptase Curve Control 1Phadia ABOYL2018-10-01
07333066011592ImmunoCAP Tryptase Calibrator StripPhadia ABOYL2016-09-23
07333066011622ImmunoCAP Tryptase Curve Control StripPhadia ABOYL2016-09-23
07333066004082ImmunoCAP Tryptase Anti-TryptasePhadia ABOYL2016-09-23
07333066000251ImmunoCAP Tryptase Calibrator StripPhadia ABOYL2016-09-23
07333066000312ImmunoCAP Tryptase Curve Control StripPhadia ABOYL2016-09-23