Streck Cell Preservative

An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by…

Registry build 21.09.26

An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains twenty four (24) 1.0 ml vials.

2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (1), Shaanxi (1).

Chinese manufacturers registered for FDA product code LEA
Manufacturer City Province Registered as Device types
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Xian Tianlong Science AND Technology Co., Ltd. Xi’An Shaanxi Manufacturer 8

Record

Regulatory record for Streck Cell Preservative
Listed by Streck LLC, United States
FDA product code LEA
Device type Preservative, Cytological
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-09-19
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 18 to 30 °C
Sizes Total volume 1 to 10 ml
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Streck Cell Preservative
Catalogue number Size Per pack Status
213350 Total Volume 1.0 ml 6 In distribution
213358 Total Volume 10 ml 2 In distribution
213355 Total Volume 1.0 ml 50 In distribution
213352 Total Volume 1.0 ml 24 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 28
PathTezt® Biocytech Corporation SDN BHD 17
ThinPrep Hologic, Inc. 12
Leica Biosystems Leica Biosystems Richmond, Inc. 2
BD CytoRich™ Clear Preservative Becton, Dickinson AND Company 1
MES: Freeze Medium Lonza Walkersville, Inc. 1
Pre-prcs Prtm Frz Sol 131P0103, 50L drum Lonza Walkersville, Inc. 1
Supmedic Supmedics Inc. 1
Fisherbrand Fisher Scientific Company L.L.C. 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer