FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
DI: 30382904440726
·
Model: 444072
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48
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Basic Information
- Brand Name
- BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
- Primary DI
- 30382904440726
- Version / Model
- 444072
- Catalog Number
- 444072
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2024-09-13
- Public Version
- 2
- Public Version Date
- 2024-09-26
- Public Version Status
- Update
- Public Device Record Key
- dd4e0809-ce6e-4375-98eb-3953036c71b9
- Distribution End Date
- 2024-09-24
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 | 00382904440725 | GS1 | ||||
| Primary | 30382904440726 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160037 | 005 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 33 Degrees Celsius