FDA.reportPublic FDA data

N/A

Primary DI
00816576026753
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J315
Catalog number
J315
Device description
Blood Agar / CLED Agar / MacConkey Agar, 15x100mm Triplate, 7ml/section. 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. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
Published
2020-05-20
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
00816576026753PrimaryGS10
00816576026746Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576026753008165760267538165760267530816576026753
00816576026746008165760267468165760267460816576026746

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

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Primary DI, Brand, Company table
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B6454P371EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
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B6451R180EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
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B645T0236EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
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