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Address: Sandhofer Strasse 116, Mannheim D-68305, Germany
FDA Registration: 9610529
Products: Myoglobin (FDA Code:
DDR), Ferritin (FDA Code:
DBF), Automated Urinalysis System (FDA Code:
KQO), Nephelometer (FDA Code:
JZW), ACTH Radioimmunoassay Test (FDA Code:
CKG), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code:
CJE), ...
Roche Diagnostics Gmbh Mannheim is a provider of automated urinalysis system and cardiac readers.
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Address: Sandhoferstrasse 116, Mannheim D-68298, Germany
www.roche.com |
Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Myoglobin (FDA Code:
DDR), Ferritin (FDA Code:
DBF), Capillary Blood Collection Tubes (FDA Code:
GIO), Analyte Specific Reagents, Asr Reagents (FDA Code:
MVU), Automated Urinalysis System (FDA Code:
KQO), Nephelometer (FDA Code:
JZW), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products
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Address: Zone Industrielle., Avenue De L Esperance, Fleurus 6220, Belgium
Phone: +32-(71)-829-211
Annual Revenues: USD 10-25 Million
Employee Count: ~260
Quality: CE Certified
Products: C Peptides of Proinsulin Radioimmunoassay Test (FDA Code:
JKD), Contract Manufacturing, Contract Sterilization, Radio Pill (FDA Code:
EXW), ...
Institut National Des Radioelements specializes in the production of radioisotopes for medical use. We also design, install and operate environmental radiological monitoring systems. We produce radiop
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FDA Code / Regulation: JKD / 862.1135 A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.