CRYOcheck Lupus Negative Control CCLN-05

GUDID 00843876000541

Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.

Precision Biologic Inc

Lupus anticoagulant marker IVD, control

• Primary Device ID: 00843876000541
• NIH Device Record Key: bede0ef6-ca31-4768-aa18-604936bb73f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck Lupus Negative Control
• Version Model Number: CCLN-05
• Catalog Number: CCLN-05
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000541 [Primary]
GS1	00843876010540 [Unit of Use]

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-06

On-Brand Devices [CRYOcheck Lupus Negative Control]

• 00843876000541: Prepared from human source plasma and recommended as a negative control in assays for lupus anti
• 00843876000534: Prepared from human source plasma and recommended as a negative control in assays for lupus anti