FDA.reportPublic FDA data

Cryptococcus Antigen Latex Test Kit

Primary DI
05032384594030
Brand
Cryptococcus Antigen Latex Test Kit
Company
OXOID LIMITED
Model
R30851501
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05032384594030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384594030050323845940305032384594030

GMDN Terms#

Term, Definition table
TermDefinition
Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
365355452
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00848838026966NAOXOID LIMITEDGMD2016-09-24
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