FDA.reportPublic FDA data

PSEUDOMONAS C-N SEL.SUPPL. 1 X 10

Primary DI
05032384011711
Brand
PSEUDOMONAS C-N SEL.SUPPL. 1 X 10
Company
OXOID LIMITED
Model
SR0102E
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822664000PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPPOxoid U.S.A., Inc.1982-09-21JSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384011711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384011711050323840117115032384011711

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium antimicrobial supplement IVDA culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365355452
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384127993REAGENT SPOT INDOLE DMACAMB1448A2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05700573075706NAK610611-22016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
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B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
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00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30