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FDA PMA

Placental alpha microglobulin-1 immunoassay

PMA Number: P160052 · 2019-10-11

ApplicantQiagen, Inc.
Decision Date2019-10-11
PMA NumberP160052
Product CodeQBB
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeTX

Device Summary

Placental alpha microglobulin-1 immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2019-10-11. The device is classified under product code QBB. It was reviewed by the TX advisory panel.

Frequently Asked Questions

What is the Placental alpha microglobulin-1 immunoassay?

Placental alpha microglobulin-1 immunoassay is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Qiagen, Inc..

When did Placental alpha microglobulin-1 immunoassay receive FDA 510(k) clearance?

The clearance date for Placental alpha microglobulin-1 immunoassay can be found in the official FDA records.

Who is the listed applicant for Placental alpha microglobulin-1 immunoassay?

The FDA 510(k) record lists Qiagen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Placental alpha microglobulin-1 immunoassay?

The FDA product code for Placental alpha microglobulin-1 immunoassay is QBB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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