FDA.reportPublic FDA data

accu-beads®

Primary DI
00858604006016
Brand
accu-beads®
Company
HAMILTON THORNE, INC.
Model
accu-beads®
Device description
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.
Published
2022-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NRFMaterial, Quality Control, Semen Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRFMaterial, Quality Control, Semen AnalysisHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858604006016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858604006016008586040060168586040060160858604006016

GMDN Terms#

Term, Definition table
TermDefinition
Sperm concentration indicator IVD, controlA material that is used to verify the performance of an assay intended to be used to indicate the concentration of sperm in a semen specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152161337
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858604006061Intelligent ICSI MicropipetteIC.3.90.xx.B2024-12-11
00858604006054LYKOS DTSLYKOS DTS2023-06-07
00858604006276ZILOS-tk™ZILOS-tk2019-11-30
00858604006290LYKOS™LYKOS2019-11-30
00858604006108IVOSIVOS2019-11-30
00858604006719CEROSCEROS2019-11-30
00858604006115GM501 Gradient 45%4GM501GR-45-102021-04-30
00858604006122GM501 Gradient 45%4GM501GR-45-502021-04-30
00858604006139GM501 Gradient 45%4GM501GR-45-1002021-04-30
00858604006221GM501 Gradient 100%4GM501G-100-1002021-04-30
00858604006238GM501 Gradient 100%4GM501G-100-2502021-04-30
00858604006245GM501 Gradient 100%4GM501G-100-5002021-04-30
00858604006146GM501 Gradient 45%4GM501GR-45-2502021-04-30
00858604006177GM501 Gradient 90%4GM501GR-90-102021-04-30
00858604006184GM501 Gradient 90%4GM501GR-90-502021-04-30
00858604006191GM501 Gradient 90%4GM501GR-90-1002021-04-30
00858604006207GM501 Gradient 90%4GM501GR-90-2502021-04-30
00858604006214GM501 Gradient 100%4GM501G-100-502021-04-30
00858604006351Intelligent ICSI MicropipetteIC.4.70.xx.C2020-02-19
00858604006320Intelligent ICSI MicropipetteIC.3.45.xx.A2019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874742652LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-16
04719874742614LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742621LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742638LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742669LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
00860010518106Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518113Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518120Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518137Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
08600105181066Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181134Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181202Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181370Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
04719874741037LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741044LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741051LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741082LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741099LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874740832LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740849LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740856LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740863LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740870LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740887LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740894LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740900LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740733LensHooke X QC Beads (For Semen)BONRAYBIO CO., LTD.NRF2019-10-07