FDA.reportPublic FDA data

N/A

Primary DI
00819398021906
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
L114
Catalog number
L114
Device description
BHI (Brain Heart Infusion) Agar with Blood, Chloramphenicol and Gentamicin, 20x125mm tube, order by the package of 20 (Brain Heart Infusion Agar with 5% Sheep Blood, Chloramphenicol, and Gentamicin) For the selective isolation of fungi
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398021913PrimaryGS10
00819398021906Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398021913008193980219138193980219130819398021913
00819398021906008193980219068193980219060819398021906

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576027958N/AW95W952020-06-08
00819398024594N/AY100Y1002020-06-08
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00816576027088HardyDisk™Z9491Z94912025-08-08
00816576026975HardyDisk™Z9485Z94852025-07-14
00816576027439 QwikIDIG06020C03IG06020C032025-06-23
00819398027199N/AZ134Z1342020-06-10
00819398027779N/AZ135Z1352020-06-10
00816576023516N/A102010202020-05-26
00816576025800TransPROTPV50TPV502024-10-08
00816576026951N/AG367G3672024-07-08
00816576026586N/AJ139J1392020-05-20
00816576026876N/AR12R122024-03-08
00819398021593N/AR63BXR63BX2024-01-15
00819398020602N/AK02K022020-05-24
00816576026838HardyCHROM™J28J282023-12-08
00816576024391AnaeroGROAG051AG0512020-05-12
00819398020725HardyDisk™Z9465Z94652023-11-21
00819398023627N/AR80R802020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B6453P3951EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B6451R0091EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P2751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P3901EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P2561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P3301EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T08001EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P2301EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T00041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T06311EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
30382902978795BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
30382902981917BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
30382902216019BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
05032384011414Campylobacter Selective Supplement (Skirrow)OXOID LIMITEDJSJ2024-08-13
05032384139811XLT-4 Selective SupplementOXOID LIMITEDJSJ2024-08-13
00850056467018OxyPRAS Plus PEA PlateOxyrase, Inc.JSJ2023-11-30
00850056467025OxyPRAS Plus BBE/KVL Bi-PlateOxyrase, Inc.JSJ2023-11-30
00850056467032OxyPRAS Anaselect Blood Agar plateOxyrase, Inc.JSJ2023-11-30
00850056467049OxyPRAS Plus KVL plateOxyrase, Inc.JSJ2023-11-30
00850056467056OxyPRAS Plus Bile Esculin plateOxyrase, Inc.JSJ2023-11-30
00850056467070KVL OxyPlateOxyrase, Inc.JSJ2023-11-30
00850056467087Modified Columbia Agar plateOxyrase, Inc.JSJ2023-11-30
00850056467094OxyPRAS Plus 3-pack: Brucella, PEA and BBE/KVL Bi-PlateOxyrase, Inc.JSJ2023-11-30
00850056467100OxyPRAS Plus 3-pack, Brucella, PEA, and KVLOxyrase, Inc.JSJ2023-11-30
B088212730010InTray® SAB+PVGBIO-MED DIAGNOSTICS, INC.JSJ2023-10-05
00810144910000Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSJ2023-09-21
00810144910017Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSJ2023-09-21
00810144910024Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSJ2023-09-21
00810144910031Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSJ2023-09-21
00810144910048Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSJ2023-09-21