NA

Primary DI
00816576020126
Brand
NA
Company
HARDY DIAGNOSTICS
Model
G47
Catalog number
G47
Device description
MRSA SCREEN PLATE (Mueller Hinton with 4% NaCl and Oxacillin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus.
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576020126PrimaryGS10
00816576021284Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576020126008165760201268165760201260816576020126
00816576021284008165760212848165760212840816576021284

GMDN Terms#

Term, Definition table
TermDefinition
MRSA agar culture medium IVD, selective antimicrobialA selective and/or differential agar culture medium containing a defined concentration of selective antimicrobials (e.g. methicillin, oxacillin, cephalosporin) intended to be used to screen for the presence of methicillin-resistant Staphylococcus aureus (MRSA) microorganisms in a clinical specimen.

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
Premarket exempt
false
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

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Primary DI, Brand, Company table
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B6453P240EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JTZ2023-06-07
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
00816576023592N/AHARDY DIAGNOSTICSJTZ2020-05-27
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
30382902211779BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902211762BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902218013BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
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05032384002900NAOXOID LIMITEDJTZ2016-09-24
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00848838002458NAREMEL, INC.JTZ2016-09-24
00848838002465NAREMEL, INC.JTZ2016-09-24
00848838002472NAREMEL, INC.JTZ2016-09-24
00848838002489NAREMEL, INC.JTZ2016-09-24
00848838003356NAREMEL, INC.JTZ2016-09-24
00848838004490NAREMEL, INC.JTZ2016-09-24
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00848838004513NAREMEL, INC.JTZ2016-09-24
00848838004520NAREMEL, INC.JTZ2016-09-24