What is FDA product code PQD?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Clinical Chemistry › Test SystemsBlood Specimen Collection Convenience Kit (Excludes Hiv)

Stradis Healthcare

Name: Stradis Healthcare
Brand: Stradis Healthcare

3 catalogue numbers from F5PG013.02, listed by Stradis Healthcare, United States, under Blood Specimen Collection Convenience Kit (Excludes Hiv). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

3catalogue 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 Healthcare
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	2022-02-10
Record revised	2022-06-17 (version 3)

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
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 50, case of 30
Distribution end date	2023-01-27

Catalogue Numbers

Catalogue numbers for Stradis Healthcare
Catalogue number	Size	Status
F5PG013.02		In distribution
F5PG014.02		In distribution
682-267R1		Withdrawn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
Everlywell Blood and Saliva Collection Kit	Everly Health, Inc.	2
Progen PRP Eclipse	Bellus Medical, LLC	2
Stradis	Stradis Healthcare	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.