FDA.reportPublic FDA data

NA

Primary DI
00816576021116
Brand
NA
Company
HARDY DIAGNOSTICS
Model
X52
Catalog number
X52
Device description
TRANSGROW(Modified Martin Lewis Agar with Lincomycin with CO2) For isolation of Neisseria gonorrhoeae. Hold bottle upright when cap is off. Do not refrigerate after inoculation.
Published
2016-09-01
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
00816576021116PrimaryGS10
00816576021376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576021116008165760211168165760211160816576021116
00816576021376008165760213768165760213760816576021376

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
20
DM exempt
true
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