FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300
DI: 00817302022155
·
Model: BL300
·
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 RGT. KIT BL-300
- Primary DI
- 00817302022155
- Version / Model
- BL300
- Catalog Number
- BL300
- 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
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d35932b6-29cb-46cf-97bb-caded6d425f8
Device Description
HbA1c (Hemoglobin A1c Direct) 2 x 100 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 |
|---|---|---|---|---|
| 57269 | Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free plasma haemoglobin in a clinical specimen, using an enzyme immunohistochemistry method. Free haemoglobin in plasma is indicative of red blood cell damage, and its detection is used as an aid in the diagnosis of haemolytic conditions (e.g., intravascular haemolysis, sickle cell anaemia, malaria) or to identify incompatible blood transfusions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302022155 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter | |
| Device Size Text, specify | Kit contains 2 R1, 2 R2 and 1 package insert | ||
| Total Volume | 25 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable on board a clinical analyzer for 30 days
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius