Henry Schein OneStep 1125547

GUDID 00304040001387

OneStep Pro Plus Mono

HENRY SCHEIN, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 00304040001387
• NIH Device Record Key: b48bb5e8-4419-4f9d-aadd-4a3df1121019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein OneStep
• Version Model Number: 1125547
• Catalog Number: 1125547
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040001387 [Primary]

FDA Product Code

• KTN: SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-24

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