FDA UDI
In Commercial Distribution
🇺🇸 United States
BD MAX™ Vaginal Panel
DI: 00382904437121
·
Model: 443712
·
BECTON, DICKINSON AND COMPANY
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD MAX™ Vaginal Panel
- Primary DI
- 00382904437121
- Version / Model
- 443712
- Catalog Number
- 443712
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-23
- Public Version
- 5
- Public Version Date
- 2022-10-20
- Public Version Status
- Update
- Public Device Record Key
- 660689e2-9f12-4717-b93f-b0dbdbb8b152
Device Description
BD MAX™ Vaginal Panel
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 |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Immunology | 866.3860 | 2 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | Microbiology | 866.3975 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48208 | Multiple-type vaginitis-associated organism 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 organisms associated with vaginitis in a clinical specimen, using a nucleic acid technique (NAT). Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904437121 | GS1 |
Customer Contacts
- Phone
- 8006388663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius