Salivabuse 18100149

GUDID 00810042681125

CP-OF Panel, -50%, 20mL

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042681125
• NIH Device Record Key: 58f48ce0-0c2e-434a-9f34-0bf1fd7db1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salivabuse
• Version Model Number: 18100149
• Catalog Number: 18100149
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042681125 [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: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [Salivabuse]

• 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