Bun Rate Reagent

GUDID 00817238010820

Bun Rate Reagent

CLINIQA CORPORATION

Urea IVD, reagent

• Primary Device ID: 00817238010820
• NIH Device Record Key: b4fe56b6-f542-46ad-bd6c-300ced8f5a0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bun Rate Reagent
• Version Model Number: R82043
• Company DUNS: 078742335
• Company Name: CLINIQA CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817238010820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012649

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-04
• Device Publish Date: 2016-08-15

On-Brand Devices [Bun Rate Reagent]

• 00817238011391: BUN Rate Reagent
• 00817238010820: Bun Rate Reagent