FDA UDI
In Commercial Distribution
🇺🇸 United States
Pan Lymphoma Cocktail (LCA+CD20+CD3+CD43)
DI: 00847627003973
·
Model: API3035AA
·
BIOCARE MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pan Lymphoma Cocktail (LCA+CD20+CD3+CD43)
- Primary DI
- 00847627003973
- Version / Model
- API3035AA
- Company Name
- BIOCARE MEDICAL LLC
- Labeler DUNS
- 806617825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-05-01
- Public Version Status
- Update
- Public Device Record Key
- ca0c1e42-8e7b-400a-aff1-b981a35e176e
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
- Yes
- 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 |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66601 | Multiple solid tumour differentiation marker IVD, antibody | Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, gastrointestinal, colon) in a clinical specimen. It is typically used in cancer-screening assays to help diagnostic differentiation between solid tumour types through detection of various types of proteins/markers (e.g., homeobox protein CDX-2, cytokeratin 7, GATA3, uroplakin). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847627003973 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius