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CD117 c-Kit PolyDetector DAB HRP Brown
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- CD117 c-Kit PolyDetector DAB HRP Brown FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- CD117/c-kit PolyDetector DAB HRP Brown Detection System is a non-biotin, 1-step polymeric detection system that allows for the Immunohistochemical detection of CD117 expression in normal and neoplastic formalin-fixed paraffin-embedded tissues. FDA UDI
- Model / Reference
- 500 tests FDA UDI
- Description
- CD117/c-kit PolyDetector DAB HRP Brown Detection System is a non-biotin, 1-step polymeric detection system that allows for the Immunohistochemical detection of CD117 expression in normal and neoplastic formalin-fixed paraffin-embedded tissues. FDA UDI
Identifiers
- Catalog Number
- BSB 0256 FDA UDI
- Primary DI / UDI-DI
- B502BSB02560 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
CD117 c-Kit PolyDetector DAB HRP Brown by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 698ce97a-55c5-4b47-a5cf-1231e8b7d8bb 34 fields · synced May 30, 2026