FDA.reportPublic FDA data

NA

Primary DI
00816576020195
Brand
NA
Company
HARDY DIAGNOSTICS
Model
J44
Catalog number
J44
Device description
CHOC. / M.L. with LINCO. BIPLATE(Chocolate Agar / Martin Lewis with Lincomycin). A biplate for the cultivation and isolation of Neisseria gonorrhoeae.
Published
2016-09-02
Public version status
Update
Distribution status
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
JTYCulture Media, For Isolation Of Pathogenic Neisseria

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTYCulture Media, For Isolation Of Pathogenic NeisseriaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576020195PrimaryGS10
00816576021338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576020195008165760201958165760201950816576020195
00816576021338008165760213388165760213380816576021338

GMDN Terms#

Term, Definition table
TermDefinition
Thayer-Martin Neisseria species agar culture medium IVDA selective and/or differential agar culture medium that uses the Thayer-Martin formulation, or modified formulation, and is intended to be used for the growth and isolation of Neisseria gonorrhoea and other Neisseria species from 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
Lot or batch
true
Expiration date on label
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
00816576028948NAHARDY DIAGNOSTICSJTY2020-03-31
00816576020072NAHARDY DIAGNOSTICSJTY2020-03-31
10382902213021BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902213038BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902215575BD BBL™ Martin-Lewis AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902215582BD BBL™ Martin-Lewis AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902215674BD BBL™ Modified Thayer-Martin (MTM II) AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902215681BD BBL™ Modified Thayer-Martin (MTM II) AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902216237BD BBL™ Chocolate II Agar/Modified Thayer-Martin AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902962714BD BBL™ Chocolate II Agar with BacitracinBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902977152BD BBL™ GC-Lect™ AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
10382902979286BD BBL™ GC-Lect™ AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902212677BD BBL™ Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902215685BD BBL™ Modified Thayer-Martin (MTM II) AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902215586BD BBL™ Martin-Lewis AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902962718BD BBL™ Chocolate II Agar with BacitracinBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902211694BD BBL™ Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902213025BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902213032BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902215579BD BBL™ Martin-Lewis AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902215678BD BBL™ Modified Thayer-Martin (MTM II) AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902216231BD BBL™ Chocolate II Agar/Modified Thayer-Martin AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902977156BD BBL™ GC-Lect™ AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
30382902979280BD BBL™ GC-Lect™ AgarBECTON, DICKINSON AND COMPANYJTY2016-12-21
M20210951MARTIN LEWIS AGARHealthlinkJTY2016-09-24
M20211001MODIFIED THAYER MARTINHealthlinkJTY2016-09-24
M20217371JEMBEC MARTIN LEWISHealthlinkJTY2016-09-24
M202173811JEMBEC MOD THAYER MARTINHealthlinkJTY2016-09-24
M2027657ML2MARTIN LEWIS G.C. SYSTEMHealthlinkJTY2016-09-24
M202V8001MARTIN LEWIS G.C. SYSTEMHealthlinkJTY2016-09-24