UREA UR220

GUDID 05055273216172

RANDOX LABORATORIES LIMITED

Urea IVD, kit, enzyme spectrophotometry

• Primary Device ID: 05055273216172
• NIH Device Record Key: 07f20d41-15e2-4b5e-9205-c8d28a54cde3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UREA
• Version Model Number: UR220
• Catalog Number: UR220
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273216172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923506

FDA Product Code

• CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [UREA]

• 05055273209600: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206975: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206968: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206951: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206944: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206937: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206920: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206913: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206906: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206869: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206852: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273216172: UR220