FDA.reportPublic FDA data

Mast Assure

Primary DI
15060392377854
Brand
Mast Assure
Company
MAST GROUP LIMITED
Model
M10135
Catalog number
M10135
Device description
M10135 - Shigella boydii Type 1 Antiserum - 1 pack of 2ml
Published
2022-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GNBAntisera, All Types, Shigella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNBAntisera, All Types, Shigella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060392377854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039237785415060392377854

GMDN Terms#

Term, Definition table
TermDefinition
Shigella boydii culture isolate antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Shigella boydii bacteria isolated by culture from a clinical specimen, using an agglutination method.

Storage And Handling#

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

Regulatory Flags#

DUNS number
212623821
Device count
1
Premarket exempt
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
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
15060392376178Mast Assure AntiseraM14294M142942021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumREMEL EUROPE LIMITEDGNB2026-05-05
15060392377762Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377786Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377793Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377892Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377946Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377953Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377960Mast Assure Antisera MAST GROUP LIMITEDGNB2024-01-09
15060392377984Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377991Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
05060472462718Polyvalent Shigella Slide Antisera - sonnei Phase 1 & 2PRO-LAB, INCORPORATEDGNB2022-12-20
05060472462725Polyvalent Shigella Slide Antisera - flexneri 1-6 X & YPRO-LAB, INCORPORATEDGNB2022-12-20
05060472462732Polyvalent Shigella Slide Antisera - dysenteriae 1-10PRO-LAB, INCORPORATEDGNB2022-12-20
05060472462749Polyvalent Shigella Slide Antisera - boydii 1-15PRO-LAB, INCORPORATEDGNB2022-12-20
15060392377878Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377885Mastr AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377908Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377922Mast AssreMAST GROUP LIMITEDGNB2022-01-05
15060392377939Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392376390Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-10-15
15060392377861Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-10-15
15060392377717Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-08-05
15060392377700Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377724Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377731Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377748Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377755Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392376345Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-07
15060392377694Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-07
00083059100952EZ-SHIGELLA One-Step Shigella species Rapid TestBIOMERICA, INC.GNB2020-07-01