Detectabuse 18030390

GUDID 00810042680753

CHRONOS MENU A, -50%, 20ml

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control
Primary Device ID00810042680753
NIH Device Record Key7b5e7bf1-84c7-4d3f-9fa1-25b5d2710590
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetectabuse
Version Model Number18030390
Catalog Number18030390
Company DUNS028007698
Company NameBIOCHEMICAL DIAGNOSTICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone631-595-9200
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042680753 [Primary]

FDA Product Code

DIFDrug Mixture Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Detectabuse]

00850004812167Negative Urine Control 10x5mL
00850004812778Negative Urine Control, 1L
00850004812761Negative Urine Control, 500mL
00850004812655Negative Urine Control 10x50mL
00850004812518Negative Urine Control 10x5mL
00850004812372Kova tox, STAT-SKREEN 17H Negative and Positive 10mL Kitbox
00850004812365Kova tox, DOA-SKREEN-H, Negative and Positive Urine Control, 10mL kitbox
00850004812150Kova Tox, DOA-SKREEN, Negative & Positive Urine Control 10mL Kitbox
00850004812143Kova tox, STAT-SKREEN 17 Negative and Positive Urine Control 10mL Kitbox
00850004812075Negative Urine Control 6x20mL
00850004812426STAT-SKREEN-H with MDMA, OXY & BUP 2x20mL KITBOX
00850004812419STAT-SKREEN with MDMA, OXY & BUP 2x20ML KITBOX
00850004812402Fentanyl (NORFENTANYL 50ng/mL) 2x5mL KITBOX
00850004812396STAT-SKREEN-H with MDMA, OXY & BUP 2x5mL KITBOX
00850004812389STAT-SKREEN with MDMA, OXY, & BUP, 2x5mL KITBOX
00850004812235NICOTINE CONTROLS (Cotinine 400ng/mL) 5mL KITBOX
00850004812181K2 Synthetic THC, JWH-018 5-PENTANOIC ACID URINE CONTROL KITBOX
00850004812662Confirm 4, Cutoff 10x50mL
00850004812648GC/MS CUTOFF +25%, 10x50mL
00850004812631GC/MS-H CUTOFF -25%,10x50mL
00850004812624GC/MS-H CUTOFF +25%, 10x50mL
00850004812594GC/MS CUTOFF -25%, 10x50mL
00850004812495STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL
00850004812488STAT-SKREEN17 POSITIVE CONTROL, 6x10mL
00850004812471DOA-SKREEN-H POSITIVE CONTROL, 6x10mL
00850004812464DOA-SKREEN POSITIVE CONTROL, 6x10mL
00850004812457STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL
00850004812440STAT-SKREEN with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL
00850004812433STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 10x5ML
00850004812310SERIES VI CUTOFF -25%, 6x20mL
00850004812303SERIES V CUTOFF -25%, 6x20mL
00850004812297SERIES V CUTOFF +25%, 6x20mL
00850004812280SERIES IV CUTOFF +25%, 6x20mL
00850004812273SERIES IV CUTOFF -25%, 6x20mL
00850004812266SERIES III CUTOFF +25% 6x20mL
00850004812259SERIES III CUTOFF -25% 6x20mL
00850004812228GC/MS-H CUTOFF
00850004812211GC/MS CUTOFF 10x50mL
00850004812174STAT-SKREEN with MDMA, OXY & BUP 2X CUTOFF POSITIVE, 10x5mL
00810042680043SERIES IV 3X Cutoff, 6x20mL
00810042680036SERIES V 3X Cutoff, 6x20mL
00810042680012SERIES III 3X CUTOFF 6x20mL
00850004812815MDMA, OXY, BUP, Cutoff +50%, 10x5mL
00850004812808MDMA, OXY, BUP, Cutoff -50%, 10x5mL
00850004812785Negative Urine Control with Stabilizer, 500mL
00850004812587SERIES VI 3X CUTOFF, 6x20mL
00850004812327SERIES VI CUTOFF +25%
00850004812990SERIES IX, CUTOFF 3X, 6x20mL
00850004812952AU/NZ SKREEN, Cutoff +50%, 20mL
00850004812945AU/NZ SKREEN, Cutoff -50%, 20mL

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.