FDA UDI
In Commercial Distribution
🇺🇸 United States
CHECK UP AMERICA CHOLESTEROL PANEL
DI: M769CHOLESTEROL801
·
Model: 80
·
Home Access Health Corporation
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CHECK UP AMERICA CHOLESTEROL PANEL
- Primary DI
- M769CHOLESTEROL801
- Version / Model
- 80
- Company Name
- Home Access Health Corporation
- Labeler DUNS
- 848511283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 2e491e8f-3c11-44e5-b13d-7b4a34133b78
Device Description
Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38092 | Capillary blood collection kit, home-use | A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M769CHOLESTEROL801 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063852 | 000 |