Intelligent Transport Cup ITCA-12M-W
GUDID 00858886006292
Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl. S.G.
NOBLE MEDICAL INC
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00858886006292 |
| NIH Device Record Key | 87f8186d-920c-4881-ba14-5584aab1b183 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intelligent Transport Cup |
| Version Model Number | ITCA-12M-W |
| Catalog Number | ITCA-12M-W |
| Company DUNS | 035967806 |
| Company Name | NOBLE MEDICAL 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 | true |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858886006292 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052115
FDA Product Code
| DKZ | Enzyme Immunoassay, Amphetamine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
Devices Manufactured by NOBLE MEDICAL INC
| 00858886006834 - Noble Drug Test Cup with AD (Urine) | 2023-11-10 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/THC50(pH/OX/CR) |
| 00858886006827 - Noble Drug Test Cup with AD (Urine) | 2023-10-30 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000(pH/OX/SG)/(GL/NI/CR) |
| 00858886006803 - Noble Drug Test Cup (Urine) | 2023-05-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25 |
| 00858886006797 - Noble Drug Test Cup (Urine) | 2023-05-19 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25 |
| 00858886006780 - Noble Drug Test Cup (Urine) | 2023-05-15 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25 |
| 00858886006773 - Noble Drug Test Cup (Urine) | 2023-02-22 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000 |
| 00858886006766 - Noble Dip Card with AD (Urine) | 2023-02-09 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/(OX/pH/SG) |
| 00858886006759 - Oraliss TM Oral Fluid Drug Screen | 2022-11-07 AMP50/BAR50/COC20/MET50/OPI40 |
Trademark Results [Intelligent Transport Cup]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELLIGENT TRANSPORT CUP 85669646 4402514 Live/Registered |
Clinical Reference Laboratory, Inc. 2012-07-05 |
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