FDA UDI
In Commercial Distribution
🇺🇸 United States
binx io
DI: 05060441760050
·
Model: V1 (CT/NG)
·
BINX HEALTH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- binx io
- Primary DI
- 05060441760050
- Version / Model
- V1 (CT/NG)
- Catalog Number
- 1.002.101
- Company Name
- BINX HEALTH LIMITED
- Labeler DUNS
- 347089851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-03
- Public Version
- 1
- Public Version Date
- 2025-09-11
- Public Version Status
- New
- Public Device Record Key
- 225c0689-36a8-419b-8dfe-48009b36c878
Device Description
binx io CT/NG cartridge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Microbiology | 866.3393 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50409 | Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060441760054 | GS1 | Shipper | 50 | In Commercial Distribution | |
| Primary | 05060441760050 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200533 | 000 |