FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hct Check - High Level
DI: 08426950046660
·
Model: 00009832450
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Hct Check - High Level
- Primary DI
- 08426950046660
- Version / Model
- 00009832450
- Catalog Number
- 00009832450
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- 01dcdc9d-f022-425b-a33c-18190b7c40da
- Distribution End Date
- 2018-03-09
Device Description
Hct Check - High Level
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| GLK | CONTROL, HEMATOCRIT | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55867 | Red blood cell count IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950046660 | GS1 | ||||
| Unit of Use | 18426950046667 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Hct check controls are stable until the expiration date shown on the ampule label when stored at 15-25 °C
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius