FDA UDI
In Commercial Distribution
🇺🇸 United States
Specimen Diluent
DI: 10888234001065
·
Model: 0066052
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Specimen Diluent
- Primary DI
- 10888234001065
- Version / Model
- 0066052
- Catalog Number
- 0066052
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-18
- Public Version
- 6
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- 674426a2-3468-449a-9fb7-79bcdd3b7b96
Device Description
Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52735 | Cell preservation/storage/dilution solution IVD | A solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001065 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK070016 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius