ClearLLab B1

ClearLLab B1
ClearLLab - B1

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PWD

Device Name: Flow Cytometric Test System For Hematopoietic Neoplasms

Device Class: 2

Physical State: Monoclonal and polyclonal antibody cocktails in panels, accessory reagents including software and beads used for analysis and acquisition of data.

Definition: Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Whole blood, bone marrow, and lymph node specimens.

Regulation Number: 864.7010

Third Party Flag: Y

Medical Specialty: HE

Device Id: 15099590670993

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