CARDIAC MARKER CONTROL TRI-LVL

GUDID 00817238010097

CARDIAC MARKER CONTROL TRI-LVL (min-pack)

CLINIQA CORPORATION

Multiple cardiac marker IVD, control

• Primary Device ID: 00817238010097
• NIH Device Record Key: a45b815b-5d28-46dc-82d4-d8dca7db910a
• Commercial Distribution Discontinuation: 2019-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CARDIAC MARKER CONTROL TRI-LVL
• Version Model Number: 91489
• 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: false
• 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	00817238010097 [Primary]

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: 4
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-08-22

On-Brand Devices [CARDIAC MARKER CONTROL TRI-LVL]

• 00817238010097: CARDIAC MARKER CONTROL TRI-LVL (min-pack)
• 00817238010080: CARDIAC MARKER CONTROL TRI-LEVEL