FDA.reportPublic FDA data

MASTALEX-MRSA

Primary DI
15060392372705
Brand
MASTALEX-MRSA
Company
MAST GROUP LIMITED
Model
RST501
Catalog number
RST501
Device description
MASTALEX-MRSA Rapid latex test for the detection of M.R.S.A.
Published
2018-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus ColoniesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062864000MASTALEX -MRSA, MODEL RST501Mast Group , Ltd.2006-10-18MYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060392372705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039237270515060392372705

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kitA collection of reagents and other associated materials intended to be used for the identification of Staphylococcus aureus bacteria isolated from a clinical specimen by culture, and for determining susceptibility of Staphylococcus aureus isolates to the antimicrobial methicillin, to identify methicillin-resistant Staphylococcus aureus (MRSA).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
212623821
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060392377762Mast Assure AntiseraM10124M101242024-01-09
15060392377786Mast Assure AntiseraM10152M101522024-01-09
15060392377793Mast Assure AntiseraM10153M101532024-01-09
15060392377892Mast Assure AntiseraM10140M101402024-01-09
15060392377946Mast Assure AntiseraM10145M101452024-01-09
15060392377953Mast Assure AntiseraM10146M101462024-01-09
15060392377960Mast Assure Antisera M10147M101472024-01-09
15060392377984Mast Assure AntiseraM10149M101492024-01-09
15060392377991Mast Assure AntiseraM10155M101552024-01-09
15060392377601Mast Assure AntiseraM11306M113062022-04-06
15060392375768Mast Assure AntiseraM10325M103252022-04-05
15060392375744Mast AssureM10323M103232022-01-05
15060392377854Mast AssureM10135M101352022-01-05
15060392377878Mast AssureM10138M101382022-01-05
15060392377885Mastr AssureM10139M101392022-01-05
15060392377908Mast AssureM10141M101412022-01-05
15060392377922Mast AssreM10143M101432022-01-05
15060392377939Mast AssureM10144M101442022-01-05
15060392376390Mast Assure AntiseraM10136M101362021-10-15
15060392377861Mast Assure AntiseraM10137M101372021-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10811877011238Clearview PBP2a SA Culture Colony TestAlere Scarborough, Inc.MYI2020-01-20
00812125010082mecA XpressFISH®ADVANDX, INC.MYI2016-11-08
05032384096442NAOXOID LIMITEDMYI2016-09-24
00816576021840NAHARDY DIAGNOSTICSMYI2016-09-23
10811877010842Alereâ„¢ PBP2a SA Culture Colony Test Alere Scarborough, Inc.MYI2016-09-01