FDA.reportPublic FDA data

MTS

Primary DI
10758750006038
Brand
MTS
Company
MICRO TYPING SYSTEMS, INC
Model
MTS9230
Catalog number
MTS9230
Device description
MTS Diluent 2
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
KSGMEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSGMedia, Potentiating For In Vitro Diagnostic UseHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9200130

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9200130

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750006038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000603810758750006038

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
10758750005949MTSMTS081001MTS0810012016-08-24
10758750006007MTSMTS085014MTS0850142016-08-24
10758750006052MTSMTS9610MTS96102018-12-21
10758750006069MTSMTS9612MTS96122018-12-21
10758750006090MTSMTS9640MTS96402018-12-21
10758750006106MTSMTS9650MTS96502016-08-24
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
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSG2023-10-13
07611969964505IH-Titration RackBio-Rad Medical Diagnostics GmbHKSG2022-03-09
07611969952205IH-Titration SolutionBio-Rad Medical Diagnostics GmbHKSG2022-03-03
00858400005107PEGAmerican National Red CrossKSG2018-09-17
00858400005121LISSAmerican National Red CrossKSG2018-09-17
10858400005104PEGAMERICAN NATIONAL RED CROSSKSG2018-09-17
10858400005128LISSAMERICAN NATIONAL RED CROSSKSG2018-09-17
23661562105445LISSDIAGASTKSG2018-05-01
07611969952182IH-LISS SolutionBio-Rad Medical Diagnostics GmbHKSG2018-04-05
07611969069934IH-LISS RackBio-Rad Medical Diagnostics GmbHKSG2017-01-20
00858352006023ELUclear HEMO BIOSCIENCE INCKSG2016-09-27
10758750006045MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750007820ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10758750007837ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10888234000167ImmuAddIMMUCOR, INC.KSG2016-04-15
10888234000235Bovine Albumin Solution 22%IMMUCOR, INC.KSG2016-04-15
10888234001775Gamma LO-IONIMMUCOR, INC.KSG2016-04-15
10888234001782Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001799Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001805Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234001812Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234000860Gamma ELU-KIT IIIMMUCOR, INC.KSG2016-04-14
10888234000877Gamma EGA KitIMMUCOR, INC.KSG2016-04-14
05060242471520Bovine Serum Albumin 22%ALBA BIOSCIENCE LIMITEDKSG2014-11-14
05060242471537ALBAhance PEGALBA BIOSCIENCE LIMITEDKSG2014-11-14