IVD Cluster - Vietnam Registration 240001627/PCBA-HCM
Access comprehensive regulatory information for IVD Cluster in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240001627/PCBA-HCM and manufactured by Agilent Technologies, Inc., Mỹ. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ VÀ CÔNG NGHỆ LIFELABS.
This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including CHEMELEX, S.A, Theo theo phụ lục, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
240001627/PCBA-HCM
000.00.19.H29-241021-0006
Theo theo phụ lục
Theo phụ lục
Technical Details
AR158 - Used in in vitro diagnosis. The iron stain is used in the laboratory to determine, by light microscopy, the presence of ferrihydrite in tissue samples. It can be used on routinely processed samples (paraffin-embedded). The preferred fixative is neutral buffered formalin. Clinical interpretation of any positive or negative stain result should be supplemented by appropriate morphological studies and controls and should be evaluated in the context of the patient's clinical history and other diagnostic tests by a pathologist. All reagents in the iron stain kit have been optimized for use on the Dako Artisan Staining System and do not require mixing or dilution. AR176 - Used in in vitro diagnosis. The Grocott's Methenamine Silver (GMS) stain is used in the laboratory to determine, by light microscopy, the presence of fungi and Pneumocystis jirovecii (previously called carinii) in tissue samples. It can be used on routinely processed samples (paraffin-embedded). The preferred fixative is neutral buffered formalin. Clinical interpretation of any positive or negative stain result should be supplemented by appropriate morphological studies and controls and should be evaluated in the context of the patient's clinical history and other diagnostic tests by a pathologist. All reagents in the GMS stain kit have been optimized for use on the Dako Artisan Staining System and do not require mixing or dilution. AR180 - Used in in vitro diagnosis. The Jones' Basement Membrane Kit is designed to be used in the laboratory to determine, by light microscopy, the presence of basement membrane in 2 micron thick tissue sections. It can be used on routinely processed samples (paraffin-embedded). The preferred fixative is neutral buffered formalin. Clinical interpretation of any positive or negative stain result should be supplemented by appropriate morphological studies and controls and should be evaluated in the context of the patient's clinical history and other diagnostic tests by a pathologist. All reagents in the Jones' Basement Membrane Kit have been optimized for use on the Dako Artisan Staining System and do not require mixing or dilution.
Dates and Status
Oct 24, 2024
The Base IVD Cluster: Triglyceride, Glucose, Total Cholesterol
Zybio Inc.
240002994/PCBB-HN
IVD Cluster: Assay for the detection of bacterial and fungal sensitivity to certain antibiotics and antifungals
HiMedia Laboratorises Pvt. Ltd.
240002151/PCBB-HN
IVD Cluster Autoimmune Diseases
Monobind, Inc.
240001752/PCBB-HCM
IVD Cluster: Testing the sensitivity of bacteria to a number of antibiotics
Oxoid Limited
240001691/PCBB-HCM
IVD Cluster: Other Specific Proteins: hsCRP, Presepsin, PCT
LSI Medience Corporation
240001182/PCBB-HN

