GUDID 00848838026966

OXOID LIMITED

Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00848838026966
NIH Device Record Key185e2ac8-fbcd-4b30-89a7-c7003f9b4c89
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR2456096
Company DUNS365355452
Company NameOXOID LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441256694238
Emailoxoid.techsupport@thermofisher.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848838026966 [Primary]

FDA Product Code

GMDAntisera, Latex Agglutination, Cryptococcus Neoformans

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by OXOID LIMITED

05032384519583 - ProSpecT Campylobacter Microplate Assay 96 Tests2024-06-28
05032384012954 - Oxoid Reaction Cards2024-06-26
05032384013036 - Oxoid Streptococcal Grouping Kit2024-06-26
05032384029587 - SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests2024-06-19
05032384029594 - TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests2024-06-19
05032384001071 - PEPTONE WATER2024-06-12
05032384003976 - MAXIMUM RECOVERY DILUENT 2024-06-12
05032384000975 - NUTRIENT BROTH2024-06-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.