Identity
- Trade Name
- Novocastra™ FDA UDI
- Generic Name
- CD19 cell marker IVD, antibody FDA UDI
- Device Name
- NCL-L-CD19-163 is intended for the qualitative identification by light microscopy of human CD19 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
- Model / Reference
- CD19-163-L-CE-H FDA UDI
- Description
- NCL-L-CD19-163 is intended for the qualitative identification by light microscopy of human CD19 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
Identifiers
- Catalog Number
- NCL-L-CD19-163 FDA UDI
- Primary DI / UDI-DI
- 05055331323743 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD19 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Novocastra™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 0df78238-9af4-490d-bf20-3b48fb909e56 37 fields · synced May 30, 2026