The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.

The FMH RapidScreen kit is intended for use in the detection of D
FMH RapidScreen - 0007893

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LIM

Device Name: Test, Screening, For D Positive Fetal Rbc'S

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.7455

Third Party Flag: N

Medical Specialty: HE

Device Id: 10888234000907

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A