NA

Primary DI
00816576028948
Brand
NA
Company
HARDY DIAGNOSTICS
Model
E130BX
Catalog number
E130BX
Device description
THAYER MARTIN, MODIFIEDHardy Diagnostics Modified Thayer Martin (MTM) is a selective medium used in qualitative procedures for the isolation of Neisseria gonorrhoeae with suppression of most other gram-negative diplococci, gram-negative bacilli, gram-positive organisms, and yeast.
Published
2020-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934331000THAYER MARTIN, MODIFIED PILL POCKETHardy Diagnostics1993-12-21JTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028948PrimaryGS10
00816576020072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028948008165760289488165760289480816576028948
00816576020072008165760200728165760200720816576020072

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
100
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
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
00848838001796NAREMEL, INC.JTY2016-09-24