FDA.reportPublic FDA data

NA

Primary DI
00816576022700
Brand
NA
Company
HARDY DIAGNOSTICS
Model
295088
Catalog number
295088
Device description
Shigella flexneri Poly B set, 2ml
Published
2017-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00816576022700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576022700008165760227008165760227000816576022700

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Shigella species 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 one or multiple species of Shigella bacteria isolated by culture from a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
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
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

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
15060392377854Mast AssureMAST GROUP LIMITEDGNB2022-01-05
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