FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Alere NMP22 BladderChek Test
DI: 10811877010774
·
Model: D1300
·
Alere Scarborough, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alere NMP22 BladderChek Test
- Primary DI
- 10811877010774
- Version / Model
- D1300
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-01
- Public Version
- 5
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- a06e148d-3c07-4ce8-b764-c72f7aa35ae4
- Distribution End Date
- 2015-10-31
Device Description
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| NAH | System, Test, Tumor Marker, For Detection Of Bladder Cancer | Unknown | 3 | |
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60572 | Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of nuclear matrix protein 22 (NMP22) [also known as nuclear mitotic apparatus protein 1] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses typically to aid in the diagnosis of urological conditions (e.g., bladder cancer, prostate cancer). It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10811877010774 | GS1 |