Rapid Response Midstream Pregnancy Test

GUDID 00722066005323

The Rapid Response hCG Pregnancy Midstream Test is a rapid, self-performing, qualitative test for the determination of human chorionic gonadotropin in human urine specimens, to aid in the early detection of pregnancy.

BTNX Inc

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00722066005323
• NIH Device Record Key: 97e7155a-87ac-485e-8b55-6f062005c5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response Midstream Pregnancy Test
• Version Model Number: HCG-1M1
• Company DUNS: 251005005
• Company Name: BTNX 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066005323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122907

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2021-12-17
• Device Publish Date: 2021-12-09

Devices Manufactured by BTNX Inc

• 00722066008294 - Rapid Response: 2024-08-23 12 Panel DOA Cup (12.11) - MOP300 OXY100 BZO300 OPI2000 MET1000 AMP1000 COC300 THC50 MDMA500 BUP10 BAR300 MTD300
• 10722066008345 - Rapid Response: 2024-08-23 One Step 6 Panel DOA Cup (6.65) - AMP1000, BUP10, BZO300, COC300, OPI2000, OXY100
• 00722066009017 - Rapid Response: 2024-08-23 10 Panel DOA Cup (10.46) -OXY100 MDMA500 COC150 BZO300 MTD300 BUP10 MET500 MOR300 AMP500 THC50
• 00722066008249 - Rapid Response: 2024-08-22 Rapid Response Fentanyl Test Cassette
• 00722066008379 - Rapid Response: 2024-08-22 Rapid Response Saliva Drug Test (COT)
• 00722066008614 - Rapid Response: 2024-08-22 D4.59-1VF- AMP1000 COC300 MOP2000 PCP25
• 00722066008621 - Rapid Response: 2024-08-22 Rapid Response Fentanyl Test Cassette
• 00722066008850 - Rapid Response: 2024-08-22 D9.28-1VF- MTD300 EDDP300 MOP300 BUP10 BZO300 COC300 AMP1000 BAR300 THC50