Alpha-Tec Systems 0003110

GUDID 00816085022482

Microvials PVA (Zn) Fix/10% Formalin 50 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 Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use

• Primary Device ID: 00816085022482
• NIH Device Record Key: c4d7e7f2-3f65-4767-a5b2-33e8dcedbd97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpha-Tec Systems
• Version Model Number: 0
• Catalog Number: 0003110
• Company DUNS: 103105524
• Company Name: Alpha-TEC Systems, Inc.
• Device Count: 50
• 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	00816085022369 [Primary]
GS1	00816085022482 [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: 2022-08-18
• Device Publish Date: 2022-08-10

On-Brand Devices [Alpha-Tec Systems]

• 00816085024103: QC1 Malaria Slide
• 00816085020228: Parasitology Stain QC Slides (+/-)
• 00816085020174: Zn PVA QC Slides
• 00816085020150: AFB Stain Control Slides
• 00816085020143: AFB Stain Control Slides
• 00816085020136: AFB Stain Control Slides
• 00816085020129: Gram Stain Control Slide
• 00816085020112: Gram Stain Control Slides With 3 Patient Wells
• 00816085020099: Gram Stain QC Slides with one specimen well
• 00816085020082: Gram Stain QC Slide
• 00816085023731: QC1 Gram Negative Slide
• 00816085023748: QC1 Gram Positive Slides
• 00816085023724: QC1 AFB Negative Slides
• 00816085023717: QC1 AFB Positive Slide
• 00816085023557: Potassium Permanganate Counterstain 8x250ml bottle
• 00816085023038: NALC Bulk 50g
• 00816085022987: NALC Bulk 100g
• 00816085021591: NAC-PAC RED (3.0%) 1x200ml
• 00816085020792: Potassium Permanganate Stain 1x250ml
• 00816085020785: TB Fluorescent Decolorizer 1x250ml
• 00816085023878: CELL-BOND Slide, 1 Red well, no background
• 00816085023885: CELL-BOND Slides, 3 black wells
• 00816085023892: CELL-BOND Slides, no wells or background
• 00816085020198: Cryptosporidium QC Slide
• 00816085023908: CELL-BOND Slides, 2 wells [15mm], red background
• 00816085023915: CELL-BOND Slides, 2 Wells, black background
• 00816085023922: CELL-BOND Slides, 1 Well, black background
• 00816085023939: CELL-BOND Slides, 1 Well, blue background
• 00816085023946: CELL-BOND Slides, 2 Red Wells
• 00816085023953: CELL-BOND Slides, 1 Well, black background
• 00816085023960: CELL-BOND Slides, 1 Well, white background
• 00816085023977: CELL-BOND Slides, 1 well, black background
• 00816085023984: CELL-BOND Slides, 1 well, black background
• 00816085020280: Trichomonas Quality Control Slide
• 00816085023588: Ziehl-Neelsen Carbolfushsin Stain 8x250ml
• 00816085023564: Auramine O/Rhodamine B Stain 8x250ml
• 00816085023526: TB Fluorescent Decolorizer 8x250ml
• 00816085023502: Auramine O Fluorescent Stain 8x250ml
• 00816085023489: Methylene Blue Counterstain 8x250ml
• 00816085023465: TB Decolorizer 8x250ml
• 00816085023441: Kinyoun Carbolfuchsin Stain 8x250ml
• 00816085021997: Thiazine Red Counterstain 8x250ml
• 00816085020853: Ziehl-Neelsen Carbolfuchsin Stain 250ml bottle
• 00816085020846: Methylene Blue Counterstain 250ml bottle
• 00816085020839: TB Decolorizer 250ml bottle
• 00816085020822: Kinyoun Carbolfuchsin Stain 250ml bottle
• 00816085020815: Thiazine Red Counterstain 250ml bottle
• 00816085020808: Auramine O Rhodamine B Stain 250ml bottle
• 00816085020778: Auramine O Stain 250ml bottle
• 00816085024127: VTM Viral Transport Medium Pack