Urine Reagent Strips, 1-parameter, blood

GUDID 00664816000076

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

LW SCIENTIFIC, INC.

Urine blood IVD, kit, colorimetric, rapid Urine blood IVD, kit, colorimetric, rapid Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical Urine blood IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 00664816000076
• NIH Device Record Key: 8c676b34-cd67-403d-a578-0f0b3ec240b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Reagent Strips, 1-parameter, blood
• Version Model Number: URS-01PR-BL77
• 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	00664816000076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023297

FDA Product Code

• JIO: Blood, Occult, Colorimetric, In Urine

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: 2019-10-07
• Device Publish Date: 2016-09-19

Devices Manufactured by LW SCIENTIFIC, INC.

• 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
• 00664816001950 - LW Scientific, Inc.: 2023-07-05 Epi-illumination module - LED 485nm excite, 510nm barrier, for Innovation & NIKON microscopes
• 00664816001967 - LW Scientific, Inc.: 2023-07-05 Epi-illumination module - LED 485nm excite, 510nm barrier, for OLYMPUS microscope
• 00664816002261 - LW Scientific, Inc.: 2023-07-05 I-4 INFINITY EPI-FLUORESCENT MICROSCOPE, PLAN, TRINOCULAR, LED, (LED 485NM)