FDA.reportPublic FDA data

Mueller Hinton Agar II

Primary DI
00860003684634
Brand
Mueller Hinton Agar II
Company
NEOGEN CORPORATION
Model
0
Catalog number
NCM0023E
Device description
(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K811049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811049000MUELLER HINTON AGARAcumedia Manufacturers, Inc.1981-04-29JTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003684634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003684634008600036846348600036846340860003684634

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
517-372-9200jgeyer@neogen.com

Regulatory Flags#

DUNS number
069550929
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003684696CLED Agar (Legacy 7122)0NCM02562022-04-08
00860003684603Mueller Hinton Agar II0NCM0023A2020-10-20
00860003684610Mueller Hinton Agar II0NCM0023B2020-10-20
00860003684627Mueller Hinton Agar II0NCM0023C2020-10-20
00860003684641Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034A2020-10-20
00860003684658Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034B2020-10-20
00860003684665Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034C2020-10-20
00860003684672Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034D2020-10-20
00860003684689Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034E2020-10-20

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
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
30382902219935BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21