FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066001912
·
Model: AUCT-1V1
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066001912
- Version / Model
- AUCT-1V1
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-05
- Public Version
- 2
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- 1d218e17-d57d-4d0a-be55-53bd119a5cca
Device Description
Liquid Diptube Urine ControlsLiquid Diptube Urine Ctl Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30219 | Multiple urine analyte IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066001912 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103387 | 000 |