FDA.reportPublic FDA data

KMRtrack Monitoring marker KMR013 (48)

Primary DI
00613745003009
Brand
KMRtrack Monitoring marker KMR013 (48)
Company
GenBio
Model
8344342-13
Published
2025-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZYGraft, Vascular, Stainless Steel Tunneler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZYGraft, Vascular, Stainless Steel TunnelerCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745003009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745003009006137450030096137450030090613745003009

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class I and II antigens in a clinical specimen, using a nucleic acid technique method (NAT).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8585929300orders@genbio.com

Regulatory Flags#

DUNS number
940425333
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)73337622026-05-15
00613745003870NGSgo®-AmpX v2 Enhancer707000112026-05-06
00613745003887NGSgo®-LibrX End Prep Enzyme200200512026-05-06
00613745003894NGSgo®-LibrX End Prep Buffer200200522026-05-06
00613745003900NGSgo®-LibrX Ligase Mix200200532026-05-06
00613745003917NGSgo®-LibrX Ligation Enhancer200200542026-05-06
00613745003924GenDx-LongMix500765212026-05-06
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)07K38-012025-12-26
00613745000091ImmunoFLOW Mycoplasma IgM Positive Control800-392539252026-04-19
00613745000145ImmunoFLOW Negative Control Mycoplasma IgM800-392139212026-04-19
00613745003863NGSgo®-AmpX v270700012026-03-30
00613745001630NGSgo Library Full Kit for Illumina IndX Plate III23423562025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IV23424562025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuite73716622025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate I23421562025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)93022102025-12-26
00613745002330NGSgo-MX11-373718642025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)93022202025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036132025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036232025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884908089783N/AN/AMedical Components, Inc.MZY2019-09-07
50884908089788N/AN/AMedical Components, Inc.MZY2019-09-07
00884908144680N/AMedical Components, Inc.MZY2019-08-28
00884908144697N/AMedical Components, Inc.MZY2019-08-28
00884908144703N/AMedical Components, Inc.MZY2019-08-28
00884908144710N/AMedical Components, Inc.MZY2019-08-28
00884908144727N/AMedical Components, Inc.MZY2019-08-28
00884908144741N/AMedical Components, Inc.MZY2019-08-28
50884908144685N/AMedical Components, Inc.MZY2019-08-28
50884908144692N/AMedical Components, Inc.MZY2019-08-28
50884908144708N/AMedical Components, Inc.MZY2019-08-28
50884908144715N/AMedical Components, Inc.MZY2019-08-28
50884908144722N/AMedical Components, Inc.MZY2019-08-28
50884908144746N/AMedical Components, Inc.MZY2019-08-28
00884908142044TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142051TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142068TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142075TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142049TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142056TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142063TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142070TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908145656N/AN/AMedical Components, Inc.MZY2019-08-10
00884908145663N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145651N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145668N/AN/AMedical Components, Inc.MZY2019-08-10
00884908039917TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
50884908039912TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
00884908031119TUNNELERMedical Components, Inc.MZY2017-05-18
00884908056402TUNNELERTUNNELERMedical Components, Inc.MZY2017-05-18