SALIVABUSE 20200101

GUDID 00810042682580

Multiple drugs of abuse IVD, control

Primary Device ID	00810042682580
NIH Device Record Key	4c4200ab-caa7-4d1b-972f-6d8da9bbce88
Commercial Distribution Status	In Commercial Distribution
Brand Name	SALIVABUSE
Version Model Number	20200101
Catalog Number	20200101
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	true

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 Issuing Agency	Device ID
GS1	00810042682580 [Primary]

DIF	Drug Mixture Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

00810042681163	Alco-screen Oral Fluid kitbox,4mL
00810042681149	CP-OF Panel, 3X, 20mL
00810042681132	CP-OF Panel, +50%, 20mL
00810042681125	CP-OF Panel, -50%, 20mL
00810042681118	Custom Oral Fluid, AU/NZ, Cutoff +50%, 5mL
00810042681101	Custom Oral Fluid, Negative, 5mL
00810042681453	ORAL FLUID NEGATIVE, 20mL
00810042681446	ORAL FLUID NEGATIVE, 5mL
00810042680005	Custom Oral Fluid, Negative, 500mL
00810042681286	Salivabuse Custom Liquid Control Oral Fluid 20mL
00810042681279	Salivabuse Custom Liquid Control Oral Fluid 5mL
00810042682658	ORAL-SKREEN, 3X Cutoff, 6x20mL
00810042682641	ORAL-SKREEN NEGATIVE, 6x20mL
00810042682634	ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
00810042682627	Oral Fluid, 3X Cutoff, 20mL
00810042682610	Oral Fluid, 2X Cutoff, 20mL
00810042682603	Oral Fluid, Cutoff +50%, 20mL
00810042682597	Oral Fluid, Cutoff -50%, 20mL
00810042682580	NEGATIVE, 20mL
00810042682573	NEGATIVE, 500mL
00810042682887	Salivabuse Custom Liquid Control Oral Fluid 25mL
00810042682979	AUNZS19 Cutoff +50%, 20mL
00810042682955	AUNZS19 Cutoff -50%, 20mL
00810042682467	AUNZS19 Cutoff +50%, 5mL
00810042681880	AUNZS19 Cutoff -50%, 5mL
00810042683563	Oral-Skreen, M2 NEGATIVE with Stabilizer, 500mL
00810042683709	OF 5 Panel, 3X Cutoff, 25mL
00810042683693	OF 6-MAM, 3X Cutoff, 25mL
00810042683686	OF Negative M2, 25mL
00810042683679	OF 6-MAM, Cutoff +50%, 25mL
00810042683662	OF 6-MAM, Cutoff -50%, 25mL
00810042683655	OF 5 Panel, Cutoff +50%, 25mL
00810042683648	OF 5 Panel, Cutoff -50%, 25mL
00810042683716	Negative, pH 6.5
00810042683808	Negative, 25mL

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