FDA UDI
In Commercial Distribution
🇺🇸 United States
uTASWako AFP-L3 Sample Dilution Buffer
DI: 14987481164465
·
Model: 997-61501
·
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- uTASWako AFP-L3 Sample Dilution Buffer
- Primary DI
- 14987481164465
- Version / Model
- 997-61501
- Catalog Number
- 997-61501
- Company Name
- FUJIFILM WAKO PURE CHEMICAL CORPORATION
- Labeler DUNS
- 690598875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-10-23
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 2ea8f3d1-d024-4207-9a6d-25ea112535c4
Device Description
In-Vitro Diagnostic Use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | Immunology | 866.6030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47211 | Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of hepatocellular carcinoma (HCC). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04987481164468 | GS1 | ||||
| Primary | 14987481164465 | GS1 | ||||
| Previous | 10856626006189 | GS1 |
Customer Contacts
- Phone
- 781-323-5300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100464 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius