Rapid Response 7 Panel Saliva Test Cup E/I Screening

GUDID 00722066006818

Rapid Response 7 Panel Saliva Test Cup E/I Screening (D7.27-2FC1E)- AMP50, COC20, MET50, OPI40, OXY20, PCP10, THC40. For employment and insurance testing.

BTNX Inc

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• Primary Device ID: 00722066006818
• NIH Device Record Key: 94eda38e-bafb-438a-8118-171b26ed49c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response 7 Panel Saliva Test Cup E/I Screening
• Version Model Number: D7.27-2FC1E
• Company DUNS: 251005005
• Company Name: BTNX Inc
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066006818 [Unit of Use]
GS1	10722066006815 [Primary]

FDA Product Code

• PUX: Test, Amphetamine, Employment And Insurance Testing, Exempt

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: 2023-05-19
• Device Publish Date: 2023-05-11

Devices Manufactured by BTNX Inc

• 00722066007402 - Rapid Response: 2024-04-09 D4.57-1V-COC300 MET1000 AMP1000 OPI2000
• 00722066007945 - Rapid Response: 2024-04-09 10 Panel One Step DOA cup - (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
• 00722066007952 - Rapid Response: 2024-04-09 One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
• 00722066008058 - Rapid Response: 2024-04-09 One Step DOA Cup MOR 2000 (Urine) (D10.1)- COC300 AMP1000 MET1000 THC50 MTD300 OPI2000 PCP25 BAR300 BZO300 TCA1000
• 00722066008096 - Rapid Response: 2024-04-09 D9.17-1VF- COC300 OPI2000 AMP1000 MET1000 BAR300 BZO300 MDMA500 MTD300 PCP25
• 00722066008126 - Rapid Response: 2024-04-09 D4.57-1VF- COC300 MET1000 AMP1000 OPI2000
• 00722066008256 - Rapid Response: 2024-04-09 Rapid Response Single/Multi DOA Panel MOR 2000 (Urine)- OXY100, MDMA500, COC300, BZO300, EDDP300, BUP10, MET1000, OPI2000, AMP10
• 00722066008263 - Rapid Response: 2024-04-09 AMP1000 BAR300 BUP10 BZO300 COC300 MET1000 MDMA500 OPI2000 MTD300 OXY100 PCP25 THC50 PPX300 TCA1000