FDA UDI
In Commercial Distribution
🇺🇸 United States
SPOTCHEM™ II Lipid Panel
DI: 00015482771232
·
Model: 77123
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- SPOTCHEM™ II Lipid Panel
- Primary DI
- 00015482771232
- Version / Model
- 77123
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c2d6d4ac-7411-4dd2-9aae-87ccd39273af
Device Description
Strip Description: For the in vitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | Clinical Chemistry | 862.1175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43440 | Dry clinical chemistry analyser IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple general clinical chemistry analytes, including electrolytes [e.g., sodium (Na+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine, liver enzymes [e.g. Lactate dehydrogenase (LDH), alkaline phosphatase (ALP)] and/or lipids and lipoproteins. It functions by measuring the amount of light reflected from strips or laminated film impregnated with dry reagents onto which a clinical specimen is placed. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00015482771232 | GS1 | ||||
| Unit of Use | 50015482771237 | GS1 |
Customer Contacts
- Phone
- +1(877)538-8872
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042443 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius