FDA UDI
In Commercial Distribution
🇺🇸 United States
BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay
DI: 00382904411268
·
Model: 441126
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay
- Primary DI
- 00382904411268
- Version / Model
- 441126
- Catalog Number
- 441126
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 1
- Public Version Date
- 2018-06-25
- Public Version Status
- New
- Public Device Record Key
- ab086da1-2fa1-4122-a70c-86164969ab94
Device Description
BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay Reagent Pack Contains: 12 each 96 Microwells: CT Q? Priming, CT Q? Amplification
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 |
|---|---|---|---|---|
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
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 | 00382904411268 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 33 Degrees Celsius