Aerospray® Cytology 12-Slide Carousel AC-195

GUDID 03661540304590

For use with the Aerospray Cytology Slide Stainer/Cytocentrifuge.

ELITECHGROUP INC.

Microscope slide stainer IVD

• Primary Device ID: 03661540304590
• NIH Device Record Key: c7d75ead-37e9-4b3e-b606-012d5b5e505b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerospray® Cytology 12-Slide Carousel
• Version Model Number: AC-195
• Catalog Number: AC-195
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• Device Count: 1
• 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: false
• 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	03661540304590 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2023-09-28
• Device Publish Date: 2023-09-20

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