API® M Medium

GUDID 03573026087364

API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip.

BIOMERIEUX SA

Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

• Primary Device ID: 03573026087364
• NIH Device Record Key: f41a96d1-e469-40f2-b5a4-ec065ab0243b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: API® M Medium
• Version Model Number: API® M Medium
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026087364 [Package]; Contains: 03573026588687; Package: [10 Units]; In Commercial Distribution
GS1	03573026588687 [Primary]

FDA Product Code

• JSH: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-10

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