Nitro-tab Ketone Tablets 4000-100

GUDID 00657498002131

Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.

STANBIO LABORATORY, L.P.

Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00657498002131
• NIH Device Record Key: 869b95de-760c-4a27-bc4a-3c8e49af2e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nitro-tab Ketone Tablets
• Version Model Number: 4000-100
• Catalog Number: 4000-100
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 100
• 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

Customer Support Contacts

• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498002131 [Primary]
GS1	00657498002148 [Unit of Use]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2019-03-19
• Device Publish Date: 2019-03-11

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