What is FDA product code PWD?

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)

Hematology › Kits and PackagesFlow Cytometric Test System For Hematopoietic Neoplasms

ClearLLab

Name: ClearLLab
Brand: ClearLLab

ClearLLab B1 is a reagent panel used in flow-cytometric immunophenotyping of white blood cells. It supplies antibodies that bind selected cell-surface markers so a flow cytometer can…

Registry build 21.09.26

ClearLLab B1 is a reagent panel used in flow-cytometric immunophenotyping of white blood cells. It supplies antibodies that bind selected cell-surface markers so a flow cytometer can characterize cell populations in a sample.

B1 is one panel within the ClearLLab reagent family. ClearLLab panels are designed for clinical immunophenotyping workflows, with the specific antibody combination depending on the panel selected.

Listed Item

ClearLLab B1

Reagent Panel

The antibodies in a panel bind surface markers on cells, which are then measured by flow cytometry. The resulting marker pattern helps identify populations of white blood cells.

The filed product is the B1 reagent panel, not a flow cytometer or a complete laboratory testing platform. Other ClearLLab panels use different marker combinations.

1manufacturer

5catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code PWD
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Biotechnology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for ClearLLab
Listed by	Beckman Coulter Ireland Inc, Ireland
FDA product code	PWD
Device type	Flow Cytometric Test System For Hematopoietic Neoplasms
Device class	Class 2
Regulation	21 CFR 864.7010
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2017-07-06
Record revised	2023-06-19 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for ClearLLab
Catalogue number	Size	Status
M		In distribution
B1		In distribution
B2		In distribution
T1		In distribution
T2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ClearLLab 10C	Beckman Coulter Ireland Inc	7

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.