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USP

CD34+ Cell Enumeration System Suitability

United States Pharmacopeia (USP) Reference Standard

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UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

−20°C

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

The USP CD34+ Cell Enumeration System Suitability Reference Standard comprises fixed and lyophilized human leukocytes, erythrocytes, and CD34+ cells derived from mobilized peripheral blood collected by apheresis of a G-CSF mobilized donor.

Application

CD34+ Cell Enumeration System Suitability reference standard intended for use in specified quality tests and assays.

Also, use to prepare system suitability standard solution during flow cytometric enumeration of cd34+ cells.

Additionally, used to assess the reagents and ensures correct gating during data acquisition and analysis, detection, and quantitation of CD34+ HSCs.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

高风险级别生物产品--人源产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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{?127? Flow cytometric enumeration of cd34+ cells}
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 41(5), 6560-6560 (2017)

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