Stradis

525-250 PRP Cup & 2 Syringes

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PQD
Manufacturer City Province Registered as Device types
Zhejiang Gongdong Medical Technology Co., Ltd. Taizhou Zhejiang Contract manufacturer 40

Record

Regulatory record for Stradis
Listed by Stradis Healthcare, United States
FDA product code PQD
Device type Blood Specimen Collection Convenience Kit (Excludes Hiv)
Device class Class 2
Regulation 21 CFR 862.1675
Premarket notification Exempt
Record published 2022-07-14
Record revised 2023-01-05 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Distribution end date 2023-01-04

Catalogue Numbers

Catalogue numbers for Stradis
Catalogue number Size Per pack Status
525-250 200 In distribution
525-250 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Everlywell Blood Collection Kit Everly Health, Inc. 12
Tasso+ Convenience Kit Tasso Inc 12
Aero-Med Aero-MED LLC 9
Cue Sample Collection Kit Cue Health, Inc. 5
Zinzino RDA Spot, UAB 5
RDA Spot RDA Spot, UAB 4
Bloodo RDA Spot, UAB 4
Stradis Healthcare Stradis Healthcare 3
Everlywell Blood and Saliva Collection Kit Everly Health, Inc. 2
Progen PRP Eclipse Bellus Medical, LLC 2
Cardinal Health Cardinal Health 200, LLC 2
LetsGetChecked Blood Sample Collection Kit (Mhtb) Privapath Diagnostics Ltd 2

Showing 12 of 79. All products under Blood Specimen Collection Convenience Kit (Excludes Hiv)

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