FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD MAX™ CT/GC/TV
DI: 00382904438241
·
Model: 443824
·
Geneohm Sciences Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD MAX™ CT/GC/TV
- Primary DI
- 00382904438241
- Version / Model
- 443824
- Catalog Number
- 443824
- Company Name
- Geneohm Sciences Canada Inc
- Labeler DUNS
- 255438483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-17
- Public Version
- 5
- Public Version Date
- 2021-11-24
- Public Version Status
- Update
- Public Device Record Key
- b7420190-5795-4ea7-b987-b425b1207bcf
- Distribution End Date
- 2019-09-03
Device Description
Kit BD Max CT/GC/TV US
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 |
|---|---|---|---|---|
| OUY | Trichomonas vaginalis nucleic acid amplification test system | Immunology | 866.3860 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00382904438241 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151589 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius