FDA.reportPublic FDA data

JEMBEC MARTIN LEWIS

Primary DI
M20217371
Brand
JEMBEC MARTIN LEWIS
Company
Healthlink
Model
1737
Catalog number
1737
Device description
JEMBEC MARTIN LEWIS
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950196000CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.1995-06-30JTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20217372PackageHIBCC10In Commercial Distribution
M20217371PrimaryHIBCC0
M20217370Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neiserria species agar culture medium IVD, basicA selective and/or differential agar culture medium intended to be used for the growth and isolation of Neisseria gonorrhoea and/or other Neisseria species from a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter100Millimeter

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-2625HLKCustomerSvc@clorox.com

Regulatory Flags#

DUNS number
079376107
Device count
10
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M202398012BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M202398023BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M20210951MARTIN LEWIS AGAR109510952016-09-24
M20211001MODIFIED THAYER MARTIN110011002016-09-24
M20211031MUELLER HINTON110311032016-09-24
M20211041MUELLER HINTON w 5% SB110411042016-09-24
M20211061MUELLER HINTON110611062016-09-24
M20211071MUELLER HINTON w 5% SB110711072016-09-24
M202173811JEMBEC MOD THAYER MARTIN173817382016-09-24
M2027657ML2MARTIN LEWIS G.C. SYSTEM7-657-ML7-657-ML2016-09-24
M202V8001MARTIN LEWIS G.C. SYSTEMV800V8002016-09-24
M20215021Bullseye Urine150215022016-09-24
M20234711PROSPORE AUTOCLAVE AMPULE 10/BOX347134712016-10-04

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
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