FDA UDI
In Commercial Distribution
🇺🇸 United States
HER2/ER/PR IHControls®
DI: 00850045519018
·
Model: Level M
·
Boston Cell Standards Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HER2/ER/PR IHControls®
- Primary DI
- 00850045519018
- Version / Model
- Level M
- Catalog Number
- BRL2U04
- Company Name
- Boston Cell Standards Inc
- Labeler DUNS
- 126775860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-14
- Public Version
- 1
- Public Version Date
- 2023-11-22
- Public Version Status
- New
- Public Device Record Key
- 68adb7f9-bb8f-4552-9a38-8b05a51afbcc
Device Description
HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
Device Characteristics
- Single Use
- No
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJW | Control Material, Her-2/Neu, Immunohistochemistry | Hematology | 864.1860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57049 | C-erbB2/Her2/neu oncoprotein IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850045519018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220163 | 000 |