DETECTABUSE 18002930
GUDID 00810042684034
OLYMPIC MC Cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
Multiple drugs of abuse IVD, control| Primary Device ID | 00810042684034 |
| NIH Device Record Key | da765540-adc9-4aa4-a3f9-049c0472645a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DETECTABUSE |
| Version Model Number | 18002930 |
| Catalog Number | 18002930 |
| 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810042684034 [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 | 2024-06-20 |
| Device Publish Date | 2024-06-12 |
On-Brand Devices [DETECTABUSE]
| 00850004812167 | Negative Urine Control 10x5mL |
| 00850004812778 | Negative Urine Control, 1L |
| 00850004812761 | Negative Urine Control, 500mL |
| 00850004812655 | Negative Urine Control 10x50mL |
| 00850004812518 | Negative Urine Control 10x5mL |
| 00850004812372 | Kova tox, STAT-SKREEN 17H Negative and Positive 10mL Kitbox |
| 00850004812365 | Kova tox, DOA-SKREEN-H, Negative and Positive Urine Control, 10mL kitbox |
| 00850004812150 | Kova Tox, DOA-SKREEN, Negative & Positive Urine Control 10mL Kitbox |
| 00850004812143 | Kova tox, STAT-SKREEN 17 Negative and Positive Urine Control 10mL Kitbox |
| 00850004812075 | Negative Urine Control 6x20mL |
| 00850004812426 | STAT-SKREEN-H with MDMA, OXY & BUP 2x20mL KITBOX |
| 00850004812419 | STAT-SKREEN with MDMA, OXY & BUP 2x20ML KITBOX |
| 00850004812402 | Fentanyl (NORFENTANYL 50ng/mL) 2x5mL KITBOX |
| 00850004812396 | STAT-SKREEN-H with MDMA, OXY & BUP 2x5mL KITBOX |
| 00850004812389 | STAT-SKREEN with MDMA, OXY, & BUP, 2x5mL KITBOX |
| 00850004812235 | NICOTINE CONTROLS (Cotinine 400ng/mL) 5mL KITBOX |
| 00850004812181 | K2 Synthetic THC, JWH-018 5-PENTANOIC ACID URINE CONTROL KITBOX |
| 00850004812662 | Confirm 4, Cutoff 10x50mL |
| 00850004812648 | GC/MS CUTOFF +25%, 10x50mL |
| 00850004812631 | GC/MS-H CUTOFF -25%,10x50mL |
| 00850004812624 | GC/MS-H CUTOFF +25%, 10x50mL |
| 00850004812594 | GC/MS CUTOFF -25%, 10x50mL |
| 00850004812495 | STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL |
| 00850004812488 | STAT-SKREEN17 POSITIVE CONTROL, 6x10mL |
| 00850004812471 | DOA-SKREEN-H POSITIVE CONTROL, 6x10mL |
| 00850004812464 | DOA-SKREEN POSITIVE CONTROL, 6x10mL |
| 00850004812457 | STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL |
| 00850004812440 | STAT-SKREEN with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL |
| 00850004812433 | STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 10x5ML |
| 00850004812310 | SERIES VI CUTOFF -25%, 6x20mL |
| 00850004812303 | SERIES V CUTOFF -25%, 6x20mL |
| 00850004812297 | SERIES V CUTOFF +25%, 6x20mL |
| 00850004812280 | SERIES IV CUTOFF +25%, 6x20mL |
| 00850004812273 | SERIES IV CUTOFF -25%, 6x20mL |
| 00850004812266 | SERIES III CUTOFF +25% 6x20mL |
| 00850004812259 | SERIES III CUTOFF -25% 6x20mL |
| 00850004812228 | GC/MS-H CUTOFF |
| 00850004812211 | GC/MS CUTOFF 10x50mL |
| 00850004812174 | STAT-SKREEN with MDMA, OXY & BUP 2X CUTOFF POSITIVE, 10x5mL |
| 00810042680043 | SERIES IV 3X Cutoff, 6x20mL |
| 00810042680036 | SERIES V 3X Cutoff, 6x20mL |
| 00810042680012 | SERIES III 3X CUTOFF 6x20mL |
| 00850004812815 | MDMA, OXY, BUP, Cutoff +50%, 10x5mL |
| 00850004812808 | MDMA, OXY, BUP, Cutoff -50%, 10x5mL |
| 00850004812785 | Negative Urine Control with Stabilizer, 500mL |
| 00850004812587 | SERIES VI 3X CUTOFF, 6x20mL |
| 00850004812327 | SERIES VI CUTOFF +25% |
| 00850004812990 | SERIES IX, CUTOFF 3X, 6x20mL |
| 00850004812952 | AU/NZ SKREEN, Cutoff +50%, 20mL |
| 00850004812945 | AU/NZ SKREEN, Cutoff -50%, 20mL |
Trademark Results [DETECTABUSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DETECTABUSE 76690701 3665387 Live/Registered |
BIOCHEMICAL DIAGNOSTICS, INC. 2008-06-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.