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Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

OAW · f · Unknown

Classification

FDA Product Code
OAW
Device class
f
Regulation
Review panel
IM
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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