Urine Reagent Strips, 1-parameter, glucose

GUDID 00664816000069

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

LW SCIENTIFIC, INC.

Urine glucose IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00664816000069
• NIH Device Record Key: b59e7d8c-40df-4ff1-bf84-0c8445854825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Reagent Strips, 1-parameter, glucose
• Version Model Number: URS-01PR-GL77
• 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
• 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
• 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	00664816000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942648

FDA Product Code

• JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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: 2016-09-19

Devices Manufactured by LW SCIENTIFIC, INC.

• 00664816003756 - LW Scientific, Inc`: 2024-07-09 MX12 Centrifuge; Digital, 12-place microtube, 12,000rpm, 110 volt
• 00664816005842 - LW Scientific, Inc.: 2024-07-08 Ready Warm tissue floatation bath
• 00664816005835 - LW Scientific: 2024-06-21 Zip-IQ Plus 6-place, 5,000 rpm centrifuge
• 00664816001431 - LW Scientific, Inc.: 2023-09-18 Water Bath - circulating, variable temp, 20 liter, 110V
• 00664816001592 - LW Scientific, Inc.: 2023-09-18 Water Bath - circulating, variable temp, 10 liter, 110V
• 00664816003824 - LW Scientific, Inc.: 2023-09-18 Water Bath - circulating, variable temp, 10 liter, 220V
• 00664816003831 - LW Scientific, Inc.: 2023-09-18 Water Bath - circulating, variable temp, 20 liter, 220V
• 00664816001943 - LW Scientific, Inc.: 2023-07-05 Epi-illumination module - LED 485nm excite, 510nm barrier, for Mi5 Epi microscope