accu-beads®

GUDID 00858604006016

accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements.

HAMILTON THORNE, INC.

Sperm concentration indicator IVD, control

• Primary Device ID: 00858604006016
• NIH Device Record Key: 08aa9145-b80f-42c5-913f-d379b2f978f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: accu-beads®
• Version Model Number: accu-beads®
• Company DUNS: 152161337
• Company Name: HAMILTON THORNE, 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: 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	00858604006016 [Primary]

FDA Product Code

• NRF: Material, Quality Control, Semen Analysis

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: 2022-04-07
• Device Publish Date: 2022-03-30

Devices Manufactured by HAMILTON THORNE, INC.

• 00858604006054 - LYKOS DTS: 2023-06-15 This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pell
• 00858604006016 - accu-beads®: 2022-04-07accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements.
• 00858604006016 - accu-beads®: 2022-04-07 accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and
• 00858604006146 - GM501 Gradient 45%: 2021-05-10 GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006177 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006184 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006191 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006207 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006214 - GM501 Gradient 100%: 2021-05-10 GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with