FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300
DI: 00817302020083
·
Model: CC300
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300
- Primary DI
- 00817302020083
- Version / Model
- CC300
- Catalog Number
- CC300
- 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
- 3d22deb0-3b6e-4581-9443-a25d97ccf2c5
Device Description
HbA1c (Hemoglobin A1c) w/ lysis buffer 2 x 90 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 |
|---|---|---|---|---|
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53316 | Glycated haemoglobin (HbA1c) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302020083 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5.5 | Milliliter | |
| Total Volume | 25 | Milliliter | |
| Total Volume | 7 | Milliliter | |
| Total Volume | 22 | Milliliter | |
| Device Size Text, specify | Kit contains 2 cartridges which contain R1, R2 & R1B, 2 Lysis buffer bottles 1 package insert and 2 user defined parameters |
Storage Conditions
- 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
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagents are stable to expiration date with stored at 2 to 8°C