Primary Device ID | 05055273206432 |
NIH Device Record Key | bf1b5e5a-9b27-4056-bdc7-9fcecbe29182 |
Commercial Distribution Discontinuation | 2016-09-24 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | THEO |
Version Model Number | TD3412 |
Catalog Number | TD3412 |
Company DUNS | 227530649 |
Company Name | RANDOX LABORATORIES LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
OTC Over-The-Counter | false |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055273206432 [Primary] |
KLS | Enzyme Immunoassay, Theophylline |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1) | 2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2) | 2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3) | 2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
05055273219043 - LIQUID CARDIAC CONTROL 1 | 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig |
05055273219050 - LIQUID CARDIAC CONTROL 2 | 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() THEO 98672933 not registered Live/Pending |
Pemberton & Associates, Inc. 2024-07-30 |
![]() THEO 98613336 not registered Live/Pending |
Boiko, Oksana Stepanivna 2024-06-21 |
![]() THEO 98613336 not registered Live/Pending |
Dekan, Teodor Oleksandrovych 2024-06-21 |
![]() THEO 98514593 not registered Live/Pending |
THEO AI INC. 2024-04-23 |
![]() THEO 98514589 not registered Live/Pending |
THEO AI INC. 2024-04-23 |
![]() THEO 98193238 not registered Live/Pending |
Maxphotonics Co., Ltd. 2023-09-22 |
![]() THEO 97414124 not registered Live/Pending |
GetHomePro, Inc. 2022-05-17 |
![]() THEO 90323055 not registered Live/Pending |
George P. McCuen 2020-11-16 |
![]() THEO 88580594 not registered Live/Pending |
Theo Chocolate Inc. 2019-08-15 |
![]() THEO 88566179 not registered Live/Pending |
Fitch, Taylor L 2019-08-04 |
![]() THEO 87877852 not registered Dead/Abandoned |
Abou Ghannam, Jean 2018-04-16 |
![]() THEO 87784920 not registered Live/Pending |
WSA OÃ 2018-02-05 |