DETECTABUSE

GUDID 00810042683198

CSCQ Specimen 1

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042683198
• NIH Device Record Key: 3761424d-3f2d-426d-be4a-6532ccb9e4e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DETECTABUSE
• Version Model Number: 18008445
• 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

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
• 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	00810042683198 [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: 2021-10-18
• Device Publish Date: 2021-10-08

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