FDA.reportPublic FDA data

BGM GALECTIN-3

Primary DI
00867444000207
Brand
BGM GALECTIN-3
Company
CORGENIX MEDICAL CORPORATION
Model
001
Device description
Galectin-3 In Vitro Diagnostic Assay
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OSXGalectin-3 In Vitro Diagnostic Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSXGalectin-3 In Vitro Diagnostic AssayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093758000BGM GALECTIN -3Bg Medicine, Inc.2010-11-17OSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867444000207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867444000207008674440002078674440002070867444000207

GMDN Terms#

Term, Definition table
TermDefinition
Galectin-3 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 galectin-3 protein in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
619834542
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855360006243REAADS Coagulation Control 1701-001701-0012016-07-14
00855360006250REAADS Coagulation Control 2702-001702-0012016-07-14
00855360006007REAADS Protein S Antigen Test kit036-001036-0012016-07-14
00855360006014REAADS Monoclonal Free Protein S Antigen051-001051-0012016-07-14
00855360006021REAADS Protein C Test Kit035-001035-0012016-05-26
00855360006038REAADS von Willebrand Factor Antigen Test Kit034-001034-0012016-07-14
00855360006069Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well)13525135252016-07-14
00855360006076Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)13529135292016-07-14
00855360006083Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well)13530135302016-07-14
00855360006113Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well)13534135342016-07-14
00855360006120Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well)13536135362016-07-14
00855360006137Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)13535135352016-07-14
00855360006175Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well)13370133702016-07-14
00855360006182Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well)13371133712016-07-14
00855360006199Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well)13372133722016-07-14
00855360006236Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)11854118542016-08-08
00855360006267REAADS von Willebrand Factor Activity Test Kit10826108262016-07-14
0085536000627411dhTxB2 Test Kit (11-Dehydro Thromboxane B2)12136121362016-08-08
00855360006045REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well)023-001023-0012016-07-14
00855360006052REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well)026-001026-0012016-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858701006162NOVADAQ®and PINPOINT®Novadaq Technologies IncOSX2016-09-23
00380740096137ARCHITECTAbbott GmbHOSX2016-09-09
00380740096144ARCHITECTAbbott GmbHOSX2016-09-09
00380740096618ARCHITECTAbbott GmbHOSX2016-09-09