FDA UDI
In Commercial Distribution
🇺🇸 United States
Control Cells
DI: 00858400005091
·
Model: 510400/510402
·
AMERICAN NATIONAL RED CROSS
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Control Cells
- Primary DI
- 00858400005091
- Version / Model
- 510400/510402
- Company Name
- AMERICAN NATIONAL RED CROSS
- Labeler DUNS
- 003255213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-21
- Public Version
- 4
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 4606e578-29d6-4c56-8e44-99307c84b0c1
Device Description
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | Hematology | 864.9650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52716 | Immunoglobulin-sensitized reagent red blood cell IVD, control | A sample of reagent red blood cells sensitized to or coated with antibodies [e.g., immunoglobulin G (IgG) or immunoglobulin M (IgM)] intended to be used to verify the performance of an assay (e.g., Coombs control) for evaluation of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20858400005095 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00858400005091 | GS1 | ||||
| Package | 10858400005098 | GS1 | Box | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK090021 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 8 Degrees Celsius