M45d Test Reagent Species

GUDID 05060446290248

MICROGEN BIOPRODUCTS LIMITED

Legionella pneumophila antigen IVD, kit, agglutination
Primary Device ID05060446290248
NIH Device Record Keyec833c9d-f10e-4c4e-9d61-eb3de8f42e28
Commercial Distribution StatusIn Commercial Distribution
Brand NameM45d Test Reagent Species
Version Model NumberM45d
Company DUNS231128802
Company NameMICROGEN BIOPRODUCTS 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
GS105060446290248 [Primary]

FDA Product Code

LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

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 Date2016-06-30

Devices Manufactured by MICROGEN BIOPRODUCTS LIMITED

05060446290019 - Salmonella Latex Kit2018-03-29
05060446290040 - Microgen Legionella2018-03-29
05060446290217 - M45a Test Reagent 12018-03-29
05060446290224 - M45b Test Reagent 2-152018-03-29
05060446290231 - M45c Positive Control2018-03-29
05060446290248 - M45d Test Reagent Species2018-03-29
05060446290248 - M45d Test Reagent Species2018-03-29

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