FDA.reportPublic FDA data

HardyCHROM

Primary DI
00816576026524
Brand
HardyCHROM
Company
HARDY DIAGNOSTICS
Model
J119
Catalog number
J119
Device description
Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.
Published
2020-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576026524PrimaryGS10
00816576026517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576026524008165760265248165760265240816576026524
00816576026517008165760265178165760265170816576026517

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819398026086N/AY62Y622020-06-09
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207025088Endocator Swabs (20pk)Vista DentalJSH2025-11-07
B6450715EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0713EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0714EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0718EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0722EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0772EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0775EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P355EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P444EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T0096EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6453P080EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B645T0386EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B645T0391EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6452B019EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-16
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00816576027125N/AHARDY DIAGNOSTICSJSH2020-06-23
00819398026352N/AHARDY DIAGNOSTICSJSH2020-06-16
00819398025140N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398025300N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398025324N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398025829N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398026062N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398026086N/AHARDY DIAGNOSTICSJSH2020-06-09
00819398026109N/AHARDY DIAGNOSTICSJSH2020-06-09