BUN Rate Reagent

GUDID 00817238011391

BUN Rate Reagent

CLINIQA CORPORATION

Urea IVD, reagent

• Primary Device ID: 00817238011391
• NIH Device Record Key: b95fc739-c812-4d61-a9a4-d207637a16b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUN Rate Reagent
• Version Model Number: R82042
• 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: false
• 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	00817238011391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012649

FDA Product Code

• CDG: Chromatography Separation/Zimmerman 17-Ketogenic Steroids

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: 2016-09-21

On-Brand Devices [BUN Rate Reagent]

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