Pure Global
Singapore HSA registration DE0016707

Cell Marque Immunohistochemistry Antibodies and Reagents [Haematologic Disorder and Blood Cancer Markers]

Singapore flagSingapore·CLASS C IVD·CellMarque Corporation·Registered December 30, 2014
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
HSA Product Code
Refer to HPR, CWC, LCS, PHU, BSB
HS Code
30029000
Registration information
Registration Number
DE0016707
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 of hematological markers or tumors of hematological origin, within the context of the parent's clinical history and other diagnostic tests evaluated by a qualified pathologist or physician.
Product Owner
Name
CellMarque Corporation
Short Name
Cell Marque
Address
6600 Sierra College Blvd., Rocklin, California, UNITED STATES
Registrant
Name
Bio Laboratories Pte Ltd
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Importer
Name
BIO LABORATORIES PTE LTD
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
Model Name(s)
Kappa (L1C1) Kappa (L1C1) Kappa (L1C1) Kappa (L1C1) Kappa (L1C1) Lambda (Lamb14) Lambda (Lamb14) Lambda (Lamb14) Lambda (Lamb14) Lambda (Lamb14) 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)
274M-94 274M-95 274M-96 274M-97 274M-98 277M-94 277M-95 277M-96 277M-97 277M-98 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 [Haematologic Disorder and Blood Cancer 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 DE0016707 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