API® EHR

GUDID 03573026099862

EHR is a reagent associated to API 20 A® (20 300)

BIOMERIEUX SA

Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent

• Primary Device ID: 03573026099862
• NIH Device Record Key: 14fb8e3a-5039-43bd-8c6f-9faecc7f85bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: API® EHR
• Version Model Number: 70520
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026099862 [Primary]

FDA Product Code

• JTO: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

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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