Urine Reagent Strips, 10-parameter

GUDID 00664816000021

Urine reagent strips; 10-parameter; 100 strips per vial

LW SCIENTIFIC, INC.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00664816000021
• NIH Device Record Key: c341b15c-a273-44f2-9556-6cf527c8bd30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Reagent Strips, 10-parameter
• Version Model Number: URS-10PR-7777
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00664816000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970250

FDA Product Code

• JRE: Refractometer For Clinical Use

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: 2016-09-16

Devices Manufactured by LW SCIENTIFIC, INC.

• 00664816006030 - LW Scientific, Inc`: 2026-03-10 Centrifuge, Portafuge, fixed speed, with 12v car adapter; without car seat
• 00664816006016 - LW Scientific: 2026-03-02 MX5 Digital, Swing-out buckets, APS 8place 50ml custom inserts, 5000rpm, 110V
• 00664816002322 - LW Scientific, Inc: 2026-02-27 Incubator; 30 Liter (1.0 cubic feet); 110v
• 00664816005682 - LW Scientific, Inc.: 2026-02-24 MXU TOUCH, Digital, 8-pl angled, 3-15ml, 3400 rpm, 90-240V
• 00664816005699 - LW Scientific, Inc.: 2026-02-24 Dry Bath Incubator, Digital, Two 20-place 2ml heat blocks, 90-240vAC
• 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