FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO Daily QC Simulated Whole Blood Quality Control Kit
DI: 04065266566086
·
Model: 6708858
·
MILLIPORE (U.K.) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ORTHO Daily QC Simulated Whole Blood Quality Control Kit
- Primary DI
- 04065266566086
- Version / Model
- 6708858
- Catalog Number
- 6708858
- Company Name
- MILLIPORE (U.K.) LIMITED
- Labeler DUNS
- 221110203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-10
- Public Version
- 1
- Public Version Date
- 2024-04-18
- Public Version Status
- New
- Public Device Record Key
- df6c6067-3ad7-408c-acb2-9f30a7398793
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 |
|---|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | Hematology | 864.9650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55864 | Non-blood cell primer/calibrator/control material IVD, reagent | A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04065266566086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK210653 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 2-8oC