FDA UDI
In Commercial Distribution
🇺🇸 United States
Mission Cholesterol Optical Check Device
DI: 00682607690077
·
Model: C121-2021
·
Acon Laboratories, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
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Basic Information
- Brand Name
- Mission Cholesterol Optical Check Device
- Primary DI
- 00682607690077
- Version / Model
- C121-2021
- Catalog Number
- C121-2021
- Company Name
- Acon Laboratories, Inc.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-03-09
- Public Version
- 1
- Public Version Date
- 2026-03-17
- Public Version Status
- New
- Public Device Record Key
- 98c56c24-d6a6-4f19-adc3-1d0bbd1f0746
Device Description
Meter optics checker
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JGY | COLORIMETRIC METHOD, TRIGLYCERIDES | Clinical Chemistry | 862.1705 | 1 |
| CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | Clinical Chemistry | 862.1175 | 1 |
| LBR | LDL & VLDL PRECIPITATION, HDL | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53359 | Total cholesterol lipid IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10682607690074 | GS1 | Inner Pack | 12 | In Commercial Distribution | |
| Primary | 00682607690077 | GS1 | ||||
| Package | 20682607690071 | GS1 | Carton | 4 | In Commercial Distribution | |
| Unit of Use | 00682607003679 | GS1 |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163406 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit