FDA.reportPublic FDA data

NA

Primary DI
00848838026966
Brand
NA
Company
OXOID LIMITED
Model
R2456096
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
GMDAntisera, Latex Agglutination, Cryptococcus Neoformans

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMDAntisera, Latex Agglutination, Cryptococcus NeoformansMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838026966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838026966008488380269668488380269660848838026966

GMDN Terms#

Term, Definition table
TermDefinition
Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Entamoeba histolytica in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.

Sterilization Methods#

Method table
Method

Contacts#

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

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
00848838028793NAREMEL, INC.GMD2016-09-24
00848838080913NAREMEL, INC.GMD2016-09-24
00816387020292IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020322IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020827IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020834IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020872IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020919IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00840733101083CALAS PronaseMERIDIAN BIOSCIENCE, INC.GMD2016-09-23
00840733101090Cryptococcal Antigen Latex Agglutination System (CALAS)MERIDIAN BIOSCIENCE, INC.GMD2016-09-23