FDA.reportPublic FDA data

N/A

Primary DI
00816576028108
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J65
Catalog number
J65
Device description
Blood Agar 5% / CLED Agar with Bile, 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. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.
Published
2020-05-24
Public version status
New
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
JSICulture Media, Selective And Differential
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028108PrimaryGS10
00816576028092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028108008165760281088165760281080816576028108
00816576028092008165760280928165760280920816576028092

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
B645T0496EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0577EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0762EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B6454P290EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P360EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P371EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P372EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P401EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454Q194EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454T207EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T0432EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6451P206EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R180EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6453P140EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P155EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P156EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P375EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P376EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B645T0236EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
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10382902217807BD BBL™ Group A Selective Strep Agar with 5% Sheep Blood (BD ssA™)BECTON, DICKINSON AND COMPANYJSI2023-11-17
30382902214107BD BBL™ Bile Esculin Agar SlantsBECTON, DICKINSON AND COMPANYJSI2023-11-16
00816576026364N/AHARDY DIAGNOSTICSJSI2022-11-15
00816576026432N/AHARDY DIAGNOSTICSJSI2022-11-15
00816576023981HardyCHROM™HARDY DIAGNOSTICSJSI2021-10-07