FDA.reportPublic FDA data

MTS

Primary DI
10758750005949
Brand
MTS
Company
MICRO TYPING SYSTEMS, INC
Model
MTS081001
Catalog number
MTS081001
Device description
MTS Monoclonal Control Card
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSFKit, Quality Control For Blood Banking ReagentsHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750005949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000594910758750005949

GMDN Terms#

Term, Definition table
TermDefinition
Antisera matrix (non-reactive) IVD, controlA material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
781421888
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750032815MTSMTS601402MTS6014022026-01-21
10758750005987MTSMTS084014MTS0840142014-10-22
10758750005994MTSMTS084024MTS0840242014-10-22
10758750005802MTSMTS5150-60MTS5150602016-08-24
10758750006113MTSMTS9680MTS96802016-08-24
10758750006007MTSMTS085014MTS0850142016-08-24
10758750006052MTSMTS9610MTS96102018-12-21
10758750006069MTSMTS9612MTS96122018-12-21
10758750006090MTSMTS9640MTS96402018-12-21
10758750006106MTSMTS9650MTS96502016-08-24
10758750006038MTSMTS9230MTS92302016-08-24
10758750006045MTSMTS9330MTS93302016-08-24
10758750005901MTSMTS080212MTS0802122014-10-22
10758750005871MTSMTS080017MTS0800172014-10-22
10758750005888MTSMTS080024MTS0800242014-10-22
10758750005932MTSMTS080515MTS0805152014-10-22
10758750005963MTSMTS081115MTS0811152014-10-22
10758750005840MTSMTS080014MTS0800142014-10-22
10758750005857MTSMTS080015MTS0800152014-10-22
10758750005864MTSMTS080016MTS0800162014-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060242473067Ortho™ Confidence Manual SystemALBA BIOSCIENCE LIMITEDKSF2026-03-12
M220762002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
M220762003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
04065266566086ORTHO Daily QC Simulated Whole Blood Quality Control KitMILLIPORE (U.K.) LIMITEDKSF2024-04-10
10888234002307Capture-R Ready Indicator Red CellsIMMUCOR, INC.KSF2022-09-03
05060242472473ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472459ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472329ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
05060242472336ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
23661562105438Neg ControlDIAGASTKSF2018-05-01
07611969952342IH-Internal QCBio-Rad Medical Diagnostics GmbHKSF2018-04-05
07611969952335IH-Basic QCBio-Rad Medical Diagnostics GmbHKSF2018-02-28
00816784020871ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00816784020888ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00858352006122MQCHEMO BIOSCIENCE INCKSF2017-06-28
00858352006139MQC-CATHEMO BIOSCIENCE INCKSF2017-06-26
05060242470943AlbaQ-Chek® ALBA BIOSCIENCE LIMITEDKSF2017-03-29
00816784020772ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-03-09
07611969952212IH-Card ControlBio-Rad Medical Diagnostics GmbHKSF2017-01-20
00858352006009Hemo-QCHEMO BIOSCIENCE INCKSF2016-10-20
00858352006016C3 Control CellsHEMO BIOSCIENCE INCKSF2016-09-29
00816784020437ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-27
05060242471162ALBAcyte IgG Sensitized Red Blood CellsALBA BIOSCIENCE LIMITEDKSF2016-09-24
00816784020024ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020031ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020048ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020055ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020062ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020123ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020215ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24