Saudi Arabia SFDA registration ME0000001000SFDAA00193
Anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody
Saudi Arabia·Chemicals·Ventana Medical Systems, Inc.·General IVD(Others)ActiveProduct information
Reagent for staining hepatocellular carcinoma
Product use
Anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody (anti-Glypican 3 (GC33)) is directed against the heparan sulfate proteoglycan, glypican 3. This antibody may be used to aid in the differentiation of hepatocellular carcinoma from normal liver or benign lesions. The antibody is intended for qualitative staining in sections of formalin-fixed, paraffin- embedded tissue.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001000SFDAA00193
- Authorization ID
- GHTF-2019-0925
- Status
- Active
- Expire Date
- May 27, 2024
Manufacturer
- Manufacturer Name
- Ventana Medical Systems, Inc.
Model information
- Model ID(s)
- 790-4564
Product accessories
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About this record
Access comprehensive regulatory information for Anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000001000SFDAA00193 and manufactured by Ventana Medical Systems, Inc..
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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