VITROS 8046872

GUDID 10758750004270

VITROS Chemistry Products ALC Slides

ORTHO-CLINICAL DIAGNOSTICS, INC.

Ethanol (ETOH) IVD, reagent

• Primary Device ID: 10758750004270
• NIH Device Record Key: 8eb9dc1a-62b2-4034-a911-1806e9765388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITROS
• Version Model Number: 8046872
• Catalog Number: 8046872
• Company DUNS: 623873044
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, 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: 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 -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750004270 [Primary]

FDA Product Code

• DMT: ENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-21
• Device Publish Date: 2016-08-23

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