Singapore HSA registration DE0016709
Cell Marque Immunohistochemistry Antibodies and Reagents [Pathogen Markers]
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
- HSA Product Code
- Refer to HPR, CWC, LCS, PHU, BSB
- HS Code
- 30029000
Registration information
- Registration Number
- DE0016709
- Registration Date
- December 30, 2014
- Retention Due Date
- December 29, 2025
Product description
The Cell marque monoclonal and polyclonal antibodies, and ancillary IHC reagents are intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded or frozen tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic and/or prognostic determination infectious disease agents within the context of the parent's clinical history and other diagnostic tests evaluated by a qualified pathologist or physician.
Product Owner
- Short Name
- Cell Marque
- Address
- 6600 Sierra College Blvd., Rocklin, California, UNITED STATES
Registrant
- Address
- 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Importer
- Address
- 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
- Model Name(s)
- CMV (DDG9/CCH2) CMV (DDG9/CCH2) CMV (DDG9/CCH2) CMV (DDG9/CCH2) CMV (DDG9/CCH2) Hepatitis B Virus Core Antigen (polyclonal) Hepatitis B Virus Core Antigen (polyclonal) Hepatitis B Virus Core Antigen (polyclonal) Hepatitis B Virus Core Antigen (polyclonal) Hepatitis B Virus Core Antigen (polyclonal) Hepatitis B Virus Surface Antigen (S1-210) Hepatitis B Virus Surface Antigen (S1-210) Hepatitis B Virus Surface Antigen (S1-210) Hepatitis B Virus Surface Antigen (S1-210) Hepatitis B Virus Surface Antigen (S1-210) Toxoplasma gondii (polyclonal) Toxoplasma gondii (polyclonal) Toxoplasma gondii (polyclonal) Toxoplasma gondii (polyclonal) Toxoplasma gondii (polyclonal) Epstein Barr Virus (CS1-4) Epstein Barr Virus (CS1-4) Epstein Barr Virus (CS1-4) Epstein Barr Virus (CS1-4) Epstein Barr Virus (CS1-4) Herpes Simplex Virus I (polyclonal) Herpes Simplex Virus I (polyclonal) Herpes Simplex Virus I (polyclonal) Herpes Simplex Virus I (polyclonal) Herpes Simplex Virus I (polyclonal) Herpes Simplex Virus II (polyclonal) Herpes Simplex Virus II (polyclonal) Herpes Simplex Virus II (polyclonal) Herpes Simplex Virus II (polyclonal) Herpes Simplex Virus II (polyclonal) Trilogy Trilogy Trilogy Trilogy Trilogy Trilogy Declere 20x conc Declere 20x conc Declere 20x conc PeroxFree Block PeroxFree Block Background Block Background Block Background Block Avidin/Biotin Block Avidin/Biotin Block IHC Wash Buffer IHC Wash Buffer IHC Wash Buffer Hematoxylin 15ml Hematoxylin 15ml Mounting Medium Mounting Medium Mouse Negative Control Mouse Negative Control Rabbit Negative Control Rabbit Negative Control PBS IHC Wash Buffer+ Tween PBS IHC Wash Buffer+ Tween TBS IHC Wash Buffer+ Tween TBS IHC Wash Buffer+ Tween Antibody Diluent Antibody Diluent Antibody Diluent Protease, ready-to-use
- Model Identifier(s)
- 213M-14 213M-15 213M-16 213M-17 213M-18 216A-14 216A-15 216A-16 216A-17 216A-18 217M-14 217M-15 217M-16 217M-17 217M-18 220A-14 220A-15 220A-16 220A-17 220A-18 245M-14 245M-15 245M-16 245M-17 245M-18 361A-14 361A-15 361A-16 361A-17 361A-18 362A-14 362A-15 362A-16 362A-17 362A-18 920P-04 920P-05 920P-06 920P-07 920P-09 920P-10 921P-04 921P-06 921P-09 926B-05 926B-09 927B-02 927B-05 927B-09 928B-00 928B-02 929B-06 929B-09 929B-10 930B-02 930B-05 931B-02 931B-03 932B-02 932B-05 933B-02 933B-05 934B-06 934B-09 935B-06 935B-09 936B-03 936B-08 936B-09 937B-02
About this record
Access comprehensive regulatory information for Cell Marque Immunohistochemistry Antibodies and Reagents [Pathogen Markers] in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0016709 and owned by CellMarque Corporation. The device was registered on December 30, 2014.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD