Identity
- Trade Name
- HER2/ER/PR IHControls® FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, control FDA UDI
- Device Name
- HER2/ER/PR IHControls® - Level H 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. FDA UDI
- Model / Reference
- Level H FDA UDI
- Description
- HER2/ER/PR IHControls® - Level H 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. FDA UDI
Identifiers
- Catalog Number
- BRLS11 FDA UDI
- Primary DI / UDI-DI
- 00850045519001 FDA UDI
- 510(k) Number
- K220163 FDA UDI
- FDA Product Code
- NJW FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, control
HER2/ER/PR IHControls® by Boston Cell Standards, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220163 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Cell Standards, Inc.
Sources (1)
- FDA UDI f9f1c3c4-7aa8-425f-9962-e4e3a8ded10e 35 fields · synced May 31, 2026