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PNI Carcinoma MultiDetector Detection Systems kits
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- PNI Carcinoma MultiDetector Detection Systems kits FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Perineural Invasion (PNI) Carcinoma MultiDetector HRP/AP Kit is a dual stain that allows for the simultaneous visualization of skin carcinomas and nerve tissue. FDA UDI
- Model / Reference
- Ready-to-use, 150 tests each FDA UDI
- Description
- Perineural Invasion (PNI) Carcinoma MultiDetector HRP/AP Kit is a dual stain that allows for the simultaneous visualization of skin carcinomas and nerve tissue. FDA UDI
Identifiers
- Catalog Number
- BSB 0353-15 FDA UDI
- Primary DI / UDI-DI
- B502BSB0353150 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
PNI Carcinoma MultiDetector Detection Systems kits 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 051f7492-c7ec-4eb8-9be7-b9ef081ffb86 34 fields · synced Jun 1, 2026