API® 20 NE

GUDID 03573026047702

API 20 NE is a standardized system for the ID of non-fastidious, non-enteric Gram-negative rods (e.g. Pseudomonas, Acinetobacter, Flavobacterium, Moraxella, etc.)

BIOMERIEUX SA

Multiple gram negative bacteria species culture isolate identification IVD, kit

• Primary Device ID: 03573026047702
• NIH Device Record Key: 2b0f9657-865a-4a92-87b2-af017b67c1dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: API® 20 NE
• Version Model Number: 20050
• 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: true
• 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	03573026047702 [Primary]

FDA Product Code

• JSS: KIT, IDENTIFICATION, ENTEROBACTERIACEAE

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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