FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D
DI: 00817302020151
·
Model: CC204-100-D
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D
- Primary DI
- 00817302020151
- Version / Model
- CC204-100-D
- Catalog Number
- CC204-100-D
- Company Name
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Labeler DUNS
- 962385787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6d9f7b3a-f066-44fb-b866-4c23577cf40e
Device Description
Lp(a) (Lipoprotein (a) 2 x 60 tests
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| DFC | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5600 | 2 |
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55018 | LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to low density lipoprotein (anti-LDL) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302020151 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Kit contains 2 reagent cartridges 1 reagent package insert and 1 user defined parameters package insert | ||
| Total Volume | 4 | Milliliter | |
| Total Volume | 15 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagents are stable to expiration date when stored at 2 to 8°C
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C