FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumipulse G TP-N Immunoreaction Cartridges Set
DI: 04987270235041
·
Model: 235041
·
FUJIREBIO INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lumipulse G TP-N Immunoreaction Cartridges Set
- Primary DI
- 04987270235041
- Version / Model
- 235041
- Company Name
- FUJIREBIO INC.
- Labeler DUNS
- 710873907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ce567422-3cf8-4bb4-ad7b-de1ca5e86413
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 |
|---|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59861 | Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987270235041 | GS1 |
Customer Contacts
- Phone
- 610-240-3800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153145 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size Type = Units per kit; Units = 2; Unit of Measure = 2mL | ||
| 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