PVA (Zn) Fix/10% Formalin 25 sets 0003102

GUDID 00816085022437

PVA (Zn) Fix/10% Formalin 25 sets

Alpha-TEC Systems, Inc.

Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use

• Primary Device ID: 00816085022437
• NIH Device Record Key: a02dc73f-3798-4a14-8b34-f3010870f0bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVA (Zn) Fix/10% Formalin 25 sets
• Version Model Number: 1
• Catalog Number: 0003102
• Company DUNS: 103105524
• Company Name: Alpha-TEC Systems, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00816085022314 [Primary]
GS1	00816085022437 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881698

FDA Product Code

• LDZ: Fixative, Alcohol Containing

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: 2022-07-28
• Device Publish Date: 2022-07-20

Devices Manufactured by Alpha-TEC Systems, Inc.

• 00816085020075 - Alpha-Tec Systems: 2022-08-19 CELL-BOND Slides, 2 wells [15mm], red background
• 00816085020105 - Alpha-Tec Systems: 2022-08-19 CELL-BOND Slide, 1 Red well, no background
• 00816085020273 - Alpha-Tec Systems: 2022-08-19 NAC-PAC N30 Tray
• 00816085020334 - Alpha-Tec Systems: 2022-08-19 CELL-BOND Slides, 1 well, black background
• 00816085020167 - Alpha-Tec Systems: 2022-08-19 Nocardia Stain Control Slides
• 00816085020655 - Alpha-Tec Systems: 2022-08-19 70% Ethanol
• 00816085020877 - Alpha-Tec Systems: 2022-08-19 NALC tablets 1x10ea
• 00816085020884 - Alpha-Tec Systems: 2022-08-19 .25g Cysteine