Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- Liquid Diptube Urine ControlsLiquid Diptube Urine Ctl Set FDA UDI
- Model / Reference
- AUCT-1V1 FDA UDI
- Description
- Liquid Diptube Urine ControlsLiquid Diptube Urine Ctl Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00722066001912 FDA UDI
- 510(k) Number
- K103387 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple urine analyte IVD, control
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, control.
- URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) — Randox Laboratories, Ltd. · Class I
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- Urine Chemistry Control Bi-Level — CLINIQA CORPORATION · Class I
- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
- ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL — QUANTIMETRIX CORP. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 1d218e17-d57d-4d0a-be55-53bd119a5cca 34 fields · synced May 31, 2026