FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206
DI: 00817302020250
·
Model: BL206
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206
- Primary DI
- 00817302020250
- Version / Model
- BL206
- Catalog Number
- BL206
- 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
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- fe7fad77-c329-40c7-b8d7-dd9bc68d886f
Device Description
ALP (Alkaline Phosphatase) 3 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 |
|---|---|---|---|---|
| CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | Clinical Chemistry | 862.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52930 | Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple alkaline phosphatase (ALP) isoenzymes 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 |
|---|---|---|---|---|---|---|
| Primary | 00817302020250 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 25 | Milliliter | |
| Device Size Text, specify | Kit contains 3 R1 and 3 R2 bottles and 1 package insert | ||
| Total Volume | 5 | 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
- After opening, the reagent is stable for 14 days when stored at 2 to 8°