FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lymphostabil
DI: 07611969953073
·
Model: 824020
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lymphostabil
- Primary DI
- 07611969953073
- Version / Model
- 824020
- Catalog Number
- 824020
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-06
- Public Version
- 3
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- 3c490546-599b-42ef-9426-98d8d345bc83
- Distribution End Date
- 2023-12-31
Device Description
For conservation of lymphocytes, free of Ca and Mg, not for infusion
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
- 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 |
|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Hematology | 864.2220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58567 | Cell culture medium IVD | A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611969953073 | GS1 |
Customer Contacts
- Phone
- 800-224-6723
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -20 Degrees Celsius