FDA.reportPublic FDA data

Mast Assure Antisera

Primary DI
15060392379254
Brand
Mast Assure Antisera
Company
MAST GROUP LIMITED
Model
M11001
Catalog number
M11001
Device description
M11001 - Vibrio cholerae Antisera Set
Published
2018-08-23
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
GSQAntiserum, Vibrio Cholerae, All Varieties

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSQAntiserum, Vibrio Cholerae, All VarietiesMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060392379254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039237925415060392379254

GMDN Terms#

Term, Definition table
TermDefinition
Vibrio cholerae antigen (multiple serotype) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serotypes of Vibrio cholerae bacteria in a clinical specimen.

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
Premarket exempt
true
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
15060392376512Mast Assure AntiseraMAST GROUP LIMITEDGSQ2021-04-09
15060392376529Mast AssureMAST GROUP LIMITEDGSQ2018-07-25
15060392376505Mast AssureMAST GROUP LIMITEDGSQ2018-05-02
15060392376536Mast AssureMAST GROUP LIMITEDGSQ2018-05-02
00816576026715NAHARDY DIAGNOSTICSGSQ2017-10-12
00816576023073NAHARDY DIAGNOSTICSGSQ2017-03-28
05056080501024NAREMEL EUROPE LIMITEDGSQ2016-12-09
00816576022113NAHARDY DIAGNOSTICSGSQ2016-09-17
00816576022267NAHARDY DIAGNOSTICSGSQ2016-09-17
00816576022335NAHARDY DIAGNOSTICSGSQ2016-09-17
00382902243014BD Difco™ Vibrio Cholerae Antiserum InabaBECTON, DICKINSON AND COMPANYGSQ2016-04-29
00382902243113BD Difco™ Vibrio Cholerae Antiserum OgawaBECTON, DICKINSON AND COMPANYGSQ2016-04-29
00382902243212BD Difco™ Vibrio cholerae Antiserum Poly Hikojima, Inaba, OgawaBECTON, DICKINSON AND COMPANYGSQ2016-04-29