Capture LISS 0066908

GUDID 10888234002291

Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.

IMMUCOR, INC.

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

• Primary Device ID: 10888234002291
• NIH Device Record Key: 540c862a-d4b1-41b4-b3e1-f5dea99e519b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture LISS
• Version Model Number: 0066908
• Catalog Number: 0066908
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• 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: true
• 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	10888234002291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK860017

FDA Product Code

• KSS: Supplies, Blood-Bank

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: 2022-09-12
• Device Publish Date: 2022-09-03

On-Brand Devices [Capture LISS]

• 10888234002147: Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
• 10888234001218: Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
• 10888234000587: Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
• 10888234000570: Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
• 10888234002291: Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the p