FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumipulse G Mesothelin Immunoreaction Cartridges
DI: 04987270235157
·
Model: 235157
·
FUJIREBIO INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lumipulse G Mesothelin Immunoreaction Cartridges
- Primary DI
- 04987270235157
- Version / Model
- 235157
- Company Name
- FUJIREBIO INC.
- Labeler DUNS
- 710873907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-01
- Public Version
- 6
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 5ff2d4e6-34df-49f6-931e-fc33db9d7266
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OAW | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63473 | Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of soluble mesothelin-related peptide (SMRP) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used as a prognostic marker to monitor the progression or recurrence of mesothelioma. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987270235157 | GS1 |
Customer Contacts
- Phone
- 610-240-3800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- right side up with care; no vibration
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius