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)

Tasso+ Convenience Kit

Name: Tasso+ Convenience Kit
Brand: Tasso+ Convenience Kit

Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.

Registry build 21.09.26

1manufacturer

12catalogue 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 Tasso+ Convenience Kit
Listed by	Tasso Inc, United States
FDA product code	PQD
Device type	Blood Specimen Collection Convenience Kit (Excludes Hiv)
Device class	Class 2
Regulation	21 CFR 862.1675
Establishment	Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-10-21
Record revised	2024-08-20 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Radiation Sterilization
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 18 to 25 °C
Distribution end date	2024-09-20

Catalogue Numbers

Catalogue numbers for Tasso+ Convenience Kit
Catalogue number	Size	Status
K1019-03		Withdrawn
K1011-01		Withdrawn
K1019-04		Withdrawn
K1011-02		Withdrawn
K1019-02		Withdrawn
K1011-04		Withdrawn
K1016-01		Withdrawn
K1016-03		Withdrawn
K1016-02		Withdrawn
K1016-04		Withdrawn
K1019-01		Withdrawn
K1011-03		Withdrawn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
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
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.