Primary Device ID | 05055273220018 |
NIH Device Record Key | 2e2dd67e-85e9-4fff-b1a3-b991f725e377 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PlaySafe™ |
Version Model Number | SCK10690 |
Catalog Number | SCK10690 |
Company DUNS | 227530649 |
Company Name | RANDOX LABORATORIES LIMITED |
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 | true |
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 | true |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com | |
Phone | 304-728-2890 |
info@randoxhealthla.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055273220018 [Primary] |
OIE | Urine Collection Kit (Excludes Hiv Testing) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-09 |
Device Publish Date | 2024-10-01 |
05055273220018 - PlaySafe™ | 2024-10-09The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted infections: (Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus I, Herpes simplex virus II, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum & Haemophilus ducreyi (chancroid). This device is intended for sample collection purpose only. Samples may be collected at home through adherence to the Instructions for Use (IFU) document or may be collected under the guidance of a medical professional. |
05055273220018 - PlaySafe™ | 2024-10-09 The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted in |
05055273216752 - Evidence MultiSTAT DOA Urine MultiPlex | 2024-09-24 The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyze |
05055273214970 - Evidence MultiSTAT | 2024-09-23 The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated |
05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL) | 2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o |
05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL) | 2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PLAYSAFE 98404511 not registered Live/Pending |
Randox Laboratories Limited 2024-02-13 |
PLAYSAFE 97231863 not registered Live/Pending |
Healthy Soils LLC 2022-01-21 |
PLAYSAFE 88918802 not registered Live/Pending |
Win Technologies Limited 2020-05-15 |
PLAYSAFE 88918781 not registered Live/Pending |
Win Technologies Limited 2020-05-15 |
PLAYSAFE 88623157 not registered Live/Pending |
EVANSTON INVESTMENTS LLC 2019-09-19 |
PLAYSAFE 87080595 not registered Dead/Abandoned |
SportsHub Technologies, LLC 2016-06-22 |
PLAYSAFE 86306772 not registered Dead/Abandoned |
Public Sector Software Limited 2014-06-11 |
PLAYSAFE 86274053 4684094 Live/Registered |
Playsafe Recreational and Consulting Services, LLC 2014-05-07 |
PLAYSAFE 86241344 4773836 Live/Registered |
Advanced Organics LLC 2014-04-03 |
PLAYSAFE 86052270 4760926 Live/Registered |
Write Stuff Enterprises, LLC 2013-08-30 |
PLAYSAFE 78139521 not registered Dead/Abandoned |
The Purdue Frederick Company 2002-06-27 |
PLAYSAFE 77879361 not registered Dead/Abandoned |
Ainsworth Game Technology Limited 2009-11-23 |