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 10c

Name: ClearLLab 10C
Brand: ClearLLab 10C

ClearLLab 10C Control Cells normal

Registry build 21.09.26

1manufacturer

7catalogue 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 10C
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	2019-03-26
Record revised	2024-10-28 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for ClearLLab 10C
Catalogue number	Size	Status
B96808		In distribution
B90003		In distribution
B96807		In distribution
B96805		In distribution
B90002		In distribution
B96806		In distribution
B99883		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ClearLLab	Beckman Coulter Ireland Inc	5

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.