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 ID00858604006016
NIH Device Record Key08aa9145-b80f-42c5-913f-d379b2f978f1
Commercial Distribution StatusIn Commercial Distribution
Brand Nameaccu-beads®
Version Model Numberaccu-beads®
Company DUNS152161337
Company NameHAMILTON THORNE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858604006016 [Primary]

FDA Product Code

NRFMaterial, Quality Control, Semen Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-07
Device Publish Date2022-03-30

Devices Manufactured by HAMILTON THORNE, INC.

00858604006054 - LYKOS DTS2023-06-15 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

Trademark Results [accu-beads]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCU-BEADS
ACCU-BEADS
74494726 1880471 Live/Registered
HAMILTON THORNE, INC.
1994-02-28

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