Urine Reagent Strips, 1-parameter, ketone

GUDID 00664816000014

Urine reagent strips; 1-parameter; ketone; 100 strips per vial

LW SCIENTIFIC, INC.

Urine ketone IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00664816000014
• NIH Device Record Key: 085f4c9b-a9a5-45f4-aa06-872092e31179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Reagent Strips, 1-parameter, ketone
• Version Model Number: URS-01PR-KE77
• Company DUNS: 785335381
• Company Name: LW SCIENTIFIC, 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: 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00664816000014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003987

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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