FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD ProbeTec™ ET Diluent (CT/GC)
DI: 30382904404520
·
Model: 440452
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
Basic Information
- Brand Name
- BD ProbeTec™ ET Diluent (CT/GC)
- Primary DI
- 30382904404520
- Version / Model
- 440452
- Catalog Number
- 440452
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2016-07-07
- Public Version
- 4
- Public Version Date
- 2022-09-15
- Public Version Status
- Update
- Public Device Record Key
- f9837335-94d4-4bcc-8acb-8e04b4b22c6b
- Distribution End Date
- 2022-04-26
Device Description
Kit Sample Diluent Swab CT/GC
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 |
|---|---|---|---|---|
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47320 | Chlamydia trachomatis 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 Chlamydia trachomatis bacteria 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 |
|---|---|---|---|---|---|---|
| Primary | 30382904404520 | GS1 | ||||
| Unit of Use | 00382904404529 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K984631 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 33 Degrees Celsius