CRYOcheck™ Lupus Positive Control

GUDID 00843876000145

Precision Biologic Inc

Lupus anticoagulant marker IVD, control

• Primary Device ID: 00843876000145
• NIH Device Record Key: 6ed47196-4b58-4d73-928c-9027a13ef259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ Lupus Positive Control
• Version Model Number: CCLP-05
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 25
• 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	00843876000145 [Primary]
GS1	00843876010144 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952623

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [CRYOcheck™ Lupus Positive Control]

• 00843876000152: CCLP-10
• 00843876000145: CCLP-05