M45a Test Reagent 1

GUDID 05060446290217

MICROGEN BIOPRODUCTS LIMITED

Legionella pneumophila antigen IVD, kit, agglutination

• Primary Device ID: 05060446290217
• NIH Device Record Key: b89b5fef-677e-41bd-bffa-4521318b4c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M45a Test Reagent 1
• Version Model Number: M45a
• Company DUNS: 231128802
• Company Name: MICROGEN BIOPRODUCTS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060446290217 [Primary]

FDA Product Code

• LHL: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-30

Devices Manufactured by MICROGEN BIOPRODUCTS LIMITED

• 05060446290019 - Salmonella Latex Kit: 2018-03-29
• 05060446290040 - Microgen Legionella: 2018-03-29
• 05060446290217 - M45a Test Reagent 1: 2018-03-29
• 05060446290217 - M45a Test Reagent 1: 2018-03-29
• 05060446290224 - M45b Test Reagent 2-15: 2018-03-29
• 05060446290231 - M45c Positive Control: 2018-03-29
• 05060446290248 - M45d Test Reagent Species: 2018-03-29