Salivabuse 18100001

GUDID 00810042681118

Custom Oral Fluid, AU/NZ, Cutoff +50%, 5mL


Multiple drugs of abuse IVD, control
Primary Device ID00810042681118
NIH Device Record Key7d544035-e407-440a-b9c5-81117d065e8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalivabuse
Version Model Number18100001
Catalog Number18100001
Company DUNS028007698
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

Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042681118 [Primary]

FDA Product Code

DIFDrug Mixture Control Materials


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 [Salivabuse]

00810042681163Alco-screen Oral Fluid kitbox,4mL
00810042681149CP-OF Panel, 3X, 20mL
00810042681132CP-OF Panel, +50%, 20mL
00810042681125CP-OF Panel, -50%, 20mL
00810042681118Custom Oral Fluid, AU/NZ, Cutoff +50%, 5mL
00810042681101Custom Oral Fluid, Negative, 5mL

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