FDA.reportPublic FDA data

NA

Primary DI
00848838003301
Brand
NA
Company
REMEL, INC.
Model
R01885
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00848838003301PrimaryGS10
00848838099731Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838003301008488380033018488380033010848838003301
00848838099731008488380997318488380997310848838099731

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
065769564
Device count
15
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

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