Primary Device ID | 00858724003148 |
NIH Device Record Key | 0de3bae7-a2fc-44fd-be31-546e4c487822 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARK™ Lamotrigine Control |
Version Model Number | 5023-0003-00 |
Catalog Number | 5023-0003-00 |
Company DUNS | 164880598 |
Company Name | ARK DIAGNOSTICS INC |
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 | 5102706270 |
customersupport@ark-tdm.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858724003148 [Primary] |
LAS | Drug Specific Control Materials |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
00812101031261 - ARK™ Pregabalin II Assay | 2024-01-01 The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and /or semi-quantitative determination of pregaba |
00812101030479 - ARK™ HS Benzodiazepine II Assay | 2021-09-08 The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines |
00812101030486 - ARK™ HS Benzodiazepine II Assay | 2021-09-08 The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines |
00812101030493 - ARK™ HS Benzodiazepine II Assay | 2021-09-08 The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines |
00812101030509 - ARK™ HS Benzodiazepine II Calibrator | 2021-09-08 ARK™ HS Benzodiazepine II Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay. |
00812101030516 - ARK™ HS Benzodiazepine II Negative Calibrator | 2021-09-08 ARK™ HS Benzodiazepine II Negative Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay. |
00812101030523 - ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator | 2021-09-08 ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Ass |
00812101030530 - ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator | 2021-09-08 ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Ass |