Company Name |
SHIMA LABORATORIES CO., LTD.
|
Address |
1-16-4, MAENO-CHO
|
City, State / Province, ZIP / Postal Code |
ITABASHI-KU, TOKYO, |
Country |
JA |
FDA Owner/Operator Phone |
-- |
FDA Medical Specialty Code |
HE - Hematology
|
FDA Product Code |
DAP |
FDA Classification Name |
FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL |
FDA Device Classification Code |
Standards
|
FDA Regulation Number |
864.7320
|
FDA Common Generic Name |
D-DIMER ASSAY & CALIBRATOR |
FDA Proprietary Device Name |
QA LATEX SHIMA (D-DIMER) |
FDA Owner / Operator Number |
9055348 |
FDA Owner / Operator Name |
SHIMA LABORATORIES CO., LTD. |
FDA Establishment Registration Number |
3003985394 |
FDA Registered Establishment Name |
SHIMA LABORATORIES CO., LTD. |
FDA Operation Code(s) |
MM - Manufacturer
|