FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
DI: 30382904438372
·
Model: 443837
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
Basic Information
- Brand Name
- BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
- Primary DI
- 30382904438372
- Version / Model
- 443837
- Catalog Number
- 443837
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2020-02-19
- Public Version
- 1
- Public Version Date
- 2020-02-27
- Public Version Status
- New
- Public Device Record Key
- ab8c5d44-1775-4099-a2da-268efa7b6bc2
Device Description
BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
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 |
|---|---|---|---|---|
| MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49994 | Human papillomavirus (HPV) 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 one or multiple strains of human papillomavirus (HPV) in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00382904438371 | GS1 | ||||
| Primary | 30382904438372 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160037 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius