FDA.reportPublic FDA data

Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y

Primary DI
05060472462725
Brand
Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y
Company
PRO-LAB, INCORPORATED
Model
PL.6901
Catalog number
PL.6901
Device description
Shigella are differentiated from the closely related Escherichia coli on the basis of pathogenicity, physiology and serology. Pro-Lab polyvalent Shigella antisera are intended to aid in the serological identification after culture, isolation and biochemical characterization of Shigella organisms. These antisera are prepared in rabbits using reference strains according to recognized guidelines, and absorbed to remove cross-reactions. Shigella antisera are supplied in 2.0 ml dropper bottles, in a ready to use format.
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
05060472462725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472462725050604724627255060472462725

GMDN Terms#

Term, Definition table
TermDefinition
Shigella flexneri culture isolate antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Shigella flexneri bacteria isolated by culture from a clinical specimen.

Regulatory Flags#

DUNS number
960418395
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10628429001223AmnioTest (Nitrazine yellow swab)PL.901PL.9012022-12-26
20628429001220AmnioTest (Nitrazine yellow swab 20 box)PL.901-20PL.901-202022-12-26
30628429001227AmnioTest (Nitrazine yellow swab 100 box)PL.901PL.9012022-12-26
10628429001742Legionella DFA Mounting MediumPL.213PL.2132022-12-25
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PL.070BPL.070B2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PL.071BPL.071B2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePL.076BPL.076B2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPL.1070PL.10702022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPL.1071PL.10712022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPL.1072PL.10722022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPL.1073PL.10732022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPL.1074PL.10742022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPL.1075PL.10752022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPL.1076PL.10762022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPL.1077PL.10772022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPL.1078PL.10782022-12-26
10628429001216E. coli O157 Antiserum (3ml)PL.6250PL.62502022-12-26
10628429001254AmnioTest Colour CardsPL.902PL.9022022-12-26
10628429000080Prolex Streptococcal Grouping Latex KitPL.030PL.0302022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APL.031PL.0312022-12-25

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
05060472462732Polyvalent Shigella Slide Antisera - dysenteriae 1-10PRO-LAB, INCORPORATEDGNB2022-12-20
05060472462749Polyvalent Shigella Slide Antisera - boydii 1-15PRO-LAB, INCORPORATEDGNB2022-12-20
15060392377854Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377878Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377885Mastr AssureMAST GROUP LIMITEDGNB2022-01-05
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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