Clarity Diagnostics CD-DOACTLS10
GUDID 00810042683143
DOA Liquid Control Urine (2x10mL Kitbox)
BIOCHEMICAL DIAGNOSTICS INC
Multiple drugs of abuse IVD, control| Primary Device ID | 00810042683143 |
| NIH Device Record Key | 5b94d1a4-8415-46d1-9406-9017bbcdf9f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clarity Diagnostics |
| Version Model Number | CD-DOACTLS10 |
| Catalog Number | CD-DOACTLS10 |
| Company DUNS | 028007698 |
| Company Name | BIOCHEMICAL 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
Customer Support Contacts
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com | |
| Phone | 631-595-9200 |
| support@biochemicaldiagnostics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810042683143 [Primary] |
FDA Product Code
| DIF | Drug Mixture Control Materials |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-17 |
| Device Publish Date | 2021-08-09 |
Devices Manufactured by BIOCHEMICAL DIAGNOSTICS INC
| 00810042684416 - DETECTABUSE | 2025-06-23 CAL MENU CD, Cutoff -50%, 50mL |
| 00810042684423 - DETECTABUSE | 2025-06-23 CAL MENU CD, Cutoff 150%, 50mL |
| 00810042684430 - DETECTABUSE | 2025-06-23 STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL |
| 00810042684447 - DETECTABUSE | 2025-06-23 STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL |
| 00810042684355 - DETECTABUSE | 2025-03-27 FENTANYL 3ng/mL 2x5mL KITBOX |
| 00810042684362 - Cliawaived | 2025-03-25 Positive QC, 25mL |
| 00810042683822 - DETECTABUSE | 2025-02-28 Toxicology Evaluation Panel II |
| 00810042684331 - DETECTABUSE | 2024-12-17 NW DOA Panel, -25%, 10mL |
Trademark Results [Clarity Diagnostics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLARITY DIAGNOSTICS 88319752 not registered Live/Pending |
Clarity Diagnostics, LLC 2019-02-28 |
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