NA

Primary DI
00816576020133
Brand
NA
Company
HARDY DIAGNOSTICS
Model
G146
Catalog number
G146
Device description
MUELLER HINTON AGARFor the cultivation and maintenance of bacteria. Not intended for disk diffusion testing because of reduced fill.
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811646000MUELLER HINTON AGARHardy Media1981-07-02JTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576020133PrimaryGS10
00816576021192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576020133008165760201338165760201330816576020133
00816576021192008165760211928165760211920816576021192

GMDN Terms#

Term, Definition table
TermDefinition
Mueller-Hinton agar antimicrobial susceptibility culture medium IVDA non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.

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
10
DM exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
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
00848838090981T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC REMEL, INC.JTZ2025-01-16
00848838020667Sensititre Demineralized WaterREMEL, INC.JTZ2024-02-22
00848838091322Sensititre Saline- Tween w/ Glass BeadsREMEL, INC.JTZ2024-02-22
00848838091360Sensititre Middlebrook 7H9 Broth w/OADCREMEL, INC.JTZ2024-02-22
00848838011177Sensititre Demineralized WaterREMEL, INC.JTZ2023-12-21
B6453P240EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JTZ2023-06-07
00848838008092REMELREMEL, INC.JTZ2022-12-22
00848838008115REMELREMEL, INC.JTZ2022-12-22
00848838011061REMELREMEL, INC.JTZ2022-12-22
00848838013294REMELREMEL, INC.JTZ2022-12-22
00848838012280REMELREMEL, INC.JTZ2022-12-22
15099590655754MicroScanBeckman Coulter, Inc.JTZ2021-06-29
00860003684603Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684610Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684627Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684634Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00816576023608N/AHARDY DIAGNOSTICSJTZ2020-05-27
00816576023592N/AHARDY DIAGNOSTICSJTZ2020-05-27
10382902211768BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902211775BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902212758BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218002BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218019BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219528BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219931BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219948BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902212752BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902218006BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219522BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219942BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21