Salmonella Latex Kit

GUDID 05060446290019

MICROGEN BIOPRODUCTS LIMITED

Multiple Salmonella species culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 05060446290019
• NIH Device Record Key: 52f7bfe8-5db8-41de-8072-4620e0f28fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salmonella Latex Kit
• Version Model Number: M42CE
• 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	05060446290019 [Primary]

FDA Product Code

• GRM: Antisera, All Groups, Salmonella Spp.

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: 2016-07-08

Devices Manufactured by MICROGEN BIOPRODUCTS LIMITED

• 05060446290019 - Salmonella Latex Kit: 2018-03-29
• 05060446290019 - Salmonella Latex Kit: 2018-03-29
• 05060446290040 - Microgen Legionella: 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