API® 20 E Reagent QC

GUDID 03573026048136

API 20 E Reagent QC test kit is a abbreviated version of API 20 E strip containing substrates for tryptophane deaminase, indole, nitrate reduction and Voges-Proskauer tests

BIOMERIEUX SA

Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit

• Primary Device ID: 03573026048136
• NIH Device Record Key: f0a63600-6178-4bed-b1ae-f97199123756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: API® 20 E Reagent QC
• Version Model Number: API® 20 E Reagent QC
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 30
• 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: true
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026048136 [Package]; Contains: 03573026588410; Package: [1 Units]; In Commercial Distribution
GS1	03573026588410 [Primary]
GS1	03573026588427 [Unit of Use]

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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