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HomeMP BIOMEDICALS, LLC › Neonatal Phenylalanine ELISA Kit (without membrane)

Neonatal Phenylalanine ELISA Kit (without membrane)

MP BIOMEDICALS, LLC · Model 07575300 · UDI-DI 00817830022320

JNB Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

Recalls

DateFirmReason
2012-11-26PerkinelmerTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
2010-01-26Bio-Rad Laboratories IncPressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.