Rapid Response

GUDID 10722066004392

Rapid Response Urinalysis Reagent Strips (Microalbumin/Creatinine)

BTNX Inc

Microalbumin IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10722066004392
• NIH Device Record Key: 236b34e4-4da4-47ff-b199-29cb54f28431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response
• Version Model Number: U2.3-1S25
• Company DUNS: 251005005
• Company Name: BTNX Inc
• Device Count: 25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066004388 [Primary]
GS1	00722066004395 [Package]; Contains: 00722066004388; Package: Box [1 Units]; In Commercial Distribution
GS1	00722066004418 [Unit of Use]
GS1	10722066004392 [Package]; Contains: 00722066004395; Package: Carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150330

FDA Product Code

• JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

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: 2019-03-11
• Device Publish Date: 2019-02-06

On-Brand Devices [Rapid Response]

• 00722066004562: D12.11-1VA
• 00722066004548: D12.5-1V
• 00722066004524: D5.1-1V
• 00722066004364: Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are
• 00722066003701: Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/B
• 00722066003695: Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 T
• 00722066003688: Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, M
• 00722066003671: Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 te
• 00722066003664: Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/PCP/BAR/BZO/BUP) - 25 tests/
• 00722066003657: Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/BUP) - 25 tests/ kit
• 00722066003640: Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative deter
• 00722066003541: Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tes
• 00722066003459: Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitat
• 00722066003428: Rapid Response Multi Drug Test Panels (AMP/COC/THC) - 25 tests/ kit are for the qualitative dete
• 00722066003404: Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitri
• 00722066003343: Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of
• 00722066003312: Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit
• 00722066003244: Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of H
• 00722066003107: Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TC
• 00722066003022: Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) -
• 00722066001974: Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative
• 00722066001905: Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection of va
• 00722066001899: Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavir
• 00722066001882: Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of hu
• 00722066001646: Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitativ
• 00722066001202: Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative detection of Hu
• 00722066001172: Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) -
• 00722066001042: Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative detection of Hum
• 00722066000915: Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MD
• 00722066000908: Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC
• 00722066000892: Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZO) - 25 tests/ k
• 00722066000885: Rapid Response Multi Drug Integrated Split Specimen Cup (COC/MET/THC/OPI/PCP) - 25 tests/ kit ar
• 00722066000847: Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit a
• 00722066000830: Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/OPI/BZO) - 25 tests/ kit are for qualitat
• 00722066000809: Rapid Response Multi Drug Test Panels (COC/AMP/MET/OPI/THC) - 25 tests/ kit are for the qualitat
• 00722066000793: Rapid Response Multi Drug Test Panels (COC/THC/AMP/OPI) - 25 tests/ kit are for the qualitative
• 00722066000786: Rapid Response Multi Drug Test Panels (MET/COC/THC) - 25 tests/ kit are for the qualitative dete
• 00722066000779: Rapid Response Multi Drug Test Panels (THC/COC/OPI) - 25 tests/ kit are for the qualitative dete
• 00722066000762: Rapid Response Multi Drug Test Panels (COC/THC) are for the qualitative detection of Cocaine and
• 00722066000731: Rapid Response Single Drug Test Cassette (THC) - 40 tests/ kit are for the qualitative detection
• 00722066000724: Rapid Response Single Drug Test Strips (THC) - 100 tests/ kit are for the qualitative detection
• 00722066000670: Rapid Response Single Drug Test Cassettes (PCP) - 40 tests/ kit are for the qualitative detectio
• 00722066000663: Rapid Response Single Drug Test Strips (PCP) - 100 tests/ kit are for the qualitative detection
• 00722066000618: Rapid Response Single Drug Test Cassette (OPI) - 40 tests/ kit are for the qualitative detection
• 00722066000601: Rapid Response Single Drug Test Strips (OPI) - 100 tests/ kit are for the qualitative detection
• 00722066000557: Rapid Response Single Drug Test Cassettes (MDMA) - 40 tests/ kit are for qualitative detection o
• 00722066000540: Rapid Response Single Drug Test Strips (MDMA) - 100 tests/ kit are for the qualitative detection
• 00722066000533: Rapid Response Single Drug Test Cassettes (COC) - 40 tests/ kit are for the qualitative detectio
• 00722066000526: Rapid Response Single Drug Test Strips (COC) - 100 tests/ kit are for the qualitative detection
• 00722066000519: Rapid Response Single Drug Test Cassettes (BZO) - 40 tests/ kit are for the qualitative detectio