SALIVABUSE 20200101

GUDID 00810042682580

NEGATIVE, 20mL

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control
Primary Device ID00810042682580
NIH Device Record Key4c4200ab-caa7-4d1b-972f-6d8da9bbce88
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALIVABUSE
Version Model Number20200101
Catalog Number20200101
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 Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042682580 [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 Date2020-08-14
Device Publish Date2020-08-06

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
00810042681453ORAL FLUID NEGATIVE, 20mL
00810042681446ORAL FLUID NEGATIVE, 5mL
00810042680005Custom Oral Fluid, Negative, 500mL
00810042681286Salivabuse Custom Liquid Control Oral Fluid 20mL
00810042681279Salivabuse Custom Liquid Control Oral Fluid 5mL
00810042682658ORAL-SKREEN, 3X Cutoff, 6x20mL
00810042682641ORAL-SKREEN NEGATIVE, 6x20mL
00810042682634ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
00810042682627Oral Fluid, 3X Cutoff, 20mL
00810042682610Oral Fluid, 2X Cutoff, 20mL
00810042682603Oral Fluid, Cutoff +50%, 20mL
00810042682597Oral Fluid, Cutoff -50%, 20mL
00810042682580NEGATIVE, 20mL
00810042682573NEGATIVE, 500mL
00810042682887Salivabuse Custom Liquid Control Oral Fluid 25mL
00810042682979AUNZS19 Cutoff +50%, 20mL
00810042682955AUNZS19 Cutoff -50%, 20mL
00810042682467AUNZS19 Cutoff +50%, 5mL
00810042681880AUNZS19 Cutoff -50%, 5mL
00810042683563Oral-Skreen, M2 NEGATIVE with Stabilizer, 500mL
00810042683709OF 5 Panel, 3X Cutoff, 25mL
00810042683693OF 6-MAM, 3X Cutoff, 25mL
00810042683686OF Negative M2, 25mL
00810042683679OF 6-MAM, Cutoff +50%, 25mL
00810042683662OF 6-MAM, Cutoff -50%, 25mL
00810042683655OF 5 Panel, Cutoff +50%, 25mL
00810042683648OF 5 Panel, Cutoff -50%, 25mL
00810042683716Negative, pH 6.5
00810042683808Negative, 25mL

Trademark Results [SALIVABUSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SALIVABUSE
SALIVABUSE
85648135 4377560 Live/Registered
Biochemical Diagnostics, Inc.
2012-06-11

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