FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00382903492015
·
Model: 349201
·
Becton, Dickinson And Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 00382903492015
- Version / Model
- 349201
- Catalog Number
- 349201
- Company Name
- Becton, Dickinson And Company
- Labeler DUNS
- 119218200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-08
- Public Version
- 9
- Public Version Date
- 2025-01-23
- Public Version Status
- Update
- Public Device Record Key
- 1eb221b0-397a-49ee-9482-c11182f7f9ce
Device Description
BD® CD3 (SK7) FITC
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| LIZ | Assay, t lymphocyte surface marker | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61272 | Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cell markers expressed on normal and/or aberrant mature lymphocytes [B lymphocytes, T lymphocytes and natural killer (NK) cells] in a clinical specimen, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382903492015 | GS1 |
Customer Contacts
- Phone
- +1(877)232-8995
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius