FDA UDI
In Commercial Distribution
🇺🇸 United States
BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack
DI: 00382904428426
·
Model: 442842
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack
- Primary DI
- 00382904428426
- Version / Model
- 442842
- Catalog Number
- 442842
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- da9bda17-99e2-44eb-a00f-3fdeadcabcde
Device Description
BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack
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 |
|---|---|---|---|---|
| 52806 | Neisseria gonorrhoeae culture isolate identification IVD, kit | A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea which has been isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904428426 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140448 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 33 Degrees Celsius