Urine Chemistry Control Bi-Level

GUDID 00817238010318

Urine Chemistry Control Bi-Level

CLINIQA CORPORATION

Multiple urine analyte IVD, control

• Primary Device ID: 00817238010318
• NIH Device Record Key: 1ea84233-0ad4-4971-98f9-13df56b43726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Chemistry Control Bi-Level
• Version Model Number: 97105
• 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: true
• 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	00817238010318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082107

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-04
• Device Publish Date: 2018-08-22

On-Brand Devices [Urine Chemistry Control Bi-Level]

• 00817238010325: Urine Chemistry Control Bi-Level
• 00817238010318: Urine Chemistry Control Bi-Level