Rapid TOX 10-3OT-030

GUDID 10694644100089

Rapid TOX 3 pan/Thc,Coc,opi300

AMERICAN BIO MEDICA CORPORATION

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

• Primary Device ID: 10694644100089
• NIH Device Record Key: 75af34a0-c2b8-4a2a-84fc-6b3599e7d8a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid TOX
• Version Model Number: 10-3OT-030
• Catalog Number: 10-3OT-030
• Company DUNS: 966665036
• Company Name: AMERICAN BIO MEDICA CORPORATION
• Device Count: 50
• 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: true
• 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: 518-758-8158
• Email: customerservice@abmc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10694644100089 [Primary]
GS1	10694644150084 [Unit of Use]

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-13
• Device Publish Date: 2016-09-23

On-Brand Devices [Rapid TOX]

• 10694644100447: RapidTox THC/COC/METH/OPI300/AMP/BZO
• 10694644100430: RapidTox cassette with METH/BZO/BAR/OPI300
• 10694644100423: 10X w/BUP/OXY NO PCP,PPX Op3 +SVT
• 10694644100393: RapTOX/ XTC/MDMA singles 50/cs
• 10694644100386: RapidTOX THC single 50/case
• 10694644100379: RapidTOX TCA single 50/case
• 10694644100362: RapidTox Methadone Single 50/b
• 10694644100355: RapidTOX Methamph single 50/cs
• 10694644100348: Rapid Tox Propoxyphene 50/case
• 10694644100331: RapidTOX PCP single 50/case
• 10694644100324: Rapid Tox OXY Single 50/case
• 10694644100317: RapidTOX Opi 2 single 50/case
• 10694644100300: RapidTox Opi 300 singles 50/cs
• 10694644100294: RapidTOX Cocaine single 50/cs
• 10694644100287: RapidTOX Benzo single 50/case
• 10694644100270: TOX Buprenorphine Single 50/bx
• 10694644100263: RapidTOX Barb single 50/case
• 10694644100256: RapidTOX Amp single 50/case
• 10694644100249: 9RapTOX/8X + MTD Opi 2000
• 10694644100232: 8 panel Rapid Tox opi 300 with SVT
• 10694644100225: 8 panel Rapid Tox opi 300
• 10694644100218: RAPIDTOX CASSETTE WITH THC/COC
• 10694644100201: 8 Rapid Tox w/BUP
• 10694644100195: RAPIDTOX WITH 3 PAD SVT, THC/M
• 10694644100188: 6pan RapidTox/5P+Meth opi2000
• 10694644100171: 6 Rapid Tox 5Z + Meth Opi2000
• 10694644100164: 5 Pan Rapid Tox w/BZO opi 300
• 10694644100157: RapidTOX thc,coc,mth,amp,op300
• 10694644100140: 5RapidTox/PCP opi 2 3 pad SVT
• 10694644100133: 5RapTox/thc,coc,amp,pcp,opi20
• 10694644100126: 5RapTox/thc,coc,bzo,meth op3
• 10694644100119: RapTOX/Coc, Thc, Bar, Bzo, Amp
• 10694644100102: RapidTOX 4/thc,coc,meth,opi3
• 10694644100096: 3 pan Rapid Tox/Thc,coc,amp
• 10694644100089: Rapid TOX 3 pan/Thc,Coc,opi300
• 10694644100072: 3 pan Rapid TOX/thc, coc, meth
• 10694644100065: 10XT CASSETTE IN LARGE POUCH,
• 10694644100058: RAPIDTOX WITH 3 PAD SVT/THC/C
• 10694644100041: 10 Panel Rapid Tox opi 2000
• 10694644100034: 10 Panel Rapid Tox opi 300
• 10694644100027: 10X w/BUP/OXY NO PCP,PPX Op2
• 10694644100010: 10X w/BUP/OXY NO PCP,PPX Op3
• 10694644150459: 5 panel RapidTox with THC/COC/OPI2000/AMP/BZO