FDA.reportPublic FDA data

Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs

Primary DI
05032384088423
Brand
Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs
Company
OXOID LIMITED
Model
CT1629B
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTNSusceptibility Test Discs, Antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTNSusceptibility Test Discs, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860153000OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCSOxoid U.S.A., Inc.1986-03-04JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384088423PrimaryGS10
05032384574964Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384088423050323840884235032384088423
05032384574964050323845749645032384574964

GMDN Terms#

Term, Definition table
TermDefinition
Antibacterial susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.

Contacts#

Phone, Email table
PhoneEmail
+441256694238oxoid.techsupport@thermofisher.com

Regulatory Flags#

DUNS number
365355452
Device count
5
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10OXOID LIMITEDJTN2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50OXOID LIMITEDJTN2025-12-12
00816576027194HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027200HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027088HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027057HardyDisk™HARDY DIAGNOSTICSJTN2025-07-18
00816576027071HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
00816576026975HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384526123Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-01
05032384574964Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-07-05
00819398020732HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020923HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020725HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398021197HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021548HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021180HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00382902322559BD BBL™ Sensi-Disc™ Cefiderocol 30 µgBECTON, DICKINSON AND COMPANYJTN2023-06-16
05032384526116NAOXOID LIMITEDJTN2021-12-07
00816576028283HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028306HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028290HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00819398028103HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028110HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028097HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
05032384140480Oxoid™ Moxifloxacin Antimicrobial Susceptibility DisksOXOID LIMITEDJTN2020-01-30
05032384506033Oxoid Meropenem/Vaborbactam Antimicrobial Susceptibility DiscsOXOID LIMITEDJTN2020-01-09