FDA.reportPublic FDA data

SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests

Primary DI
05032384029587
Brand
SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests
Company
OXOID LIMITED
Model
TD0900A
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855233000DIAGNOSTIC REAGENT SET-RPLAOxoid U.S.A., Inc.1986-11-04GTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384029587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384029587050323840295875032384029587

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus multiple enterotoxin antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple enterotoxin antigens produced by Staphylococcus aureus bacteria in a clinical specimen, using an agglutination method.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10628429000455Prolex Staph Positive ControlPRO-LAB, INCORPORATEDGTN2022-12-25
10628429000462Prolex Staph Xtra Latex Kit (100 tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000479Prolex Staph Xtra Latex Kit (300 tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000509Prolex Latex Reagent Control Negative (StaphXtra)PRO-LAB, INCORPORATEDGTN2022-12-25
00819398028035StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028042StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028059StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028011StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
05056080501499Staphaurex (120 test)REMEL EUROPE LIMITEDGTN2021-07-21
05056080501505Staphaurex (400 test)REMEL EUROPE LIMITEDGTN2021-07-21
00382902409151BD BBL™ Staphyloslide™ Latex Test KitBECTON, DICKINSON AND COMPANYGTN2018-05-25
00382902409168BD BBL™ Staphyloslide™ Latex Test KitBECTON, DICKINSON AND COMPANYGTN2018-05-25