FDA.reportPublic FDA data

EliA ß2-Glycoprotein I IgM Well

Primary DI
07333066010809
Brand
EliA ß2-Glycoprotein I IgM Well
Company
Phadia AB
Model
DECC055330
Catalog number
DECC055330
Device description
EliA ß2-Glycoprotein I IgM Well
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
MSVSystem,test,antibodies,b2 - glycoprotein i (b2 - gpi)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091845000CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.2010-06-07MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010809PackageGS14In Commercial Distribution
07333066014760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010809073330660108097333066010809
07333066014760073330660147607333066014760

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to beta-2-glycoprotein I in a clinical specimen, using a fluorescent immunoassay method.

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
08426951011216HemosIL CL Anti-ß2 Glycoprotein-I IgMINSTRUMENTATION LABORATORY COMPANYMSV2026-04-08
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08426951289257QUANTA Flash® B2GP1 IgA ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289264QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289271QUANTA Flash® B2GP1 IgM ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951298778HemosIL AcuStar Anti-B2GPI Domain 1INSTRUMENTATION LABORATORY COMPANYMSV2018-07-17
B24235B2SHUE010Anti-Beta 2 Glycoprotein Screen ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MSV2017-08-28
00845714002427Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002434Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002441Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002458Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
04250289503082AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-03-02
04250289503075AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-03-01
04250289502825AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502832AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502849AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289503099AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-12-09
00845714002939IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-10-27
04250289500852AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2016-09-27
04250289500869AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
04250289500951AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
00816879020229Autostat II Anti-B2-Glycoprotein I IgGHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020236Autostat II Anti-B2-Glycoprotein I IgMHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020243Autostat II Anti-B2-Glycoprotein I IgAHYCOR BIOMEDICAL LLCMSV2016-09-26
00845714004353IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-09-24
07333066014746EliA ß2-Glycoprotein I IgA WellPhadia ABMSV2016-09-23
07333066014753EliA ß2-Glycoprotein I IgG WellPhadia ABMSV2016-09-23
07333066014760EliA ß2-Glycoprotein I IgM WellPhadia ABMSV2016-09-23