FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 10722066007409
·
Model: D4.57-1V
·
BTNX Inc
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 10722066007409
- Version / Model
- D4.57-1V
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-04-01
- Public Version
- 1
- Public Version Date
- 2024-04-09
- Public Version Status
- New
- Public Device Record Key
- 2100cc4f-c2aa-460f-8a57-0a6b18912ff8
Device Description
D4.57-1V-COC300 MET1000 AMP1000 OPI2000
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 862.3650 | 2 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | 862.3100 | 2 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | 862.3250 | 2 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | 862.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00722066007402 | GS1 | ||||
| Primary | 10722066007409 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180349 | 000 |