EXTRACTION ENZYME

GUDID 05032384013111

OXOID LIMITED

Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent
Primary Device ID05032384013111
NIH Device Record Key7a2c0f41-fa48-48dc-808b-5441879b4974
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTRACTION ENZYME
Version Model NumberDR0593G
Company DUNS365355452
Company NameOXOID LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384013111 [Primary]

FDA Product Code

GTZAntisera, All Groups, Streptococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-04

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