FDA.reportPublic FDA data

NA

Primary DI
00816576022113
Brand
NA
Company
HARDY DIAGNOSTICS
Model
293831
Catalog number
293831
Device description
V.cholerae Poly As
Published
2016-09-17
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
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
00816576022113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576022113008165760221138165760221130816576022113

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Vibrio species culture isolate identification 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 differentiation and/or identification of one or multiple species of Vibrio 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
15060392376512Mast Assure AntiseraMAST GROUP LIMITEDGSQ2021-04-09
15060392379254Mast Assure AntiseraMAST GROUP LIMITEDGSQ2018-08-23
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
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