What is FDA product code QKI?

This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › MiscellaneousMedia, Reproductive, Exempt

CaseBioscience®

Name: CaseBioscience®
Brand: CaseBioscience®

CaseBioscience® PBS1X-Dulbecco's Phosphate Buffered Saline Solution 500 mL

Registry build 21.09.26

2manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code QKI
Manufacturer	City	Province	Registered as	Device types
Shenzhen VitaVitro Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7
Arsci Biomedical Inc.	Jiaxing	Zhejiang	Manufacturer	2

Record

Regulatory record for CaseBioscience®
Listed by	Casebioscience, Inc., Canada
FDA product code	QKI
Device type	Media, Reproductive, Exempt
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Private-label distributor, Manufacturer
Premarket notification	Exempt
Record published	2024-01-31
Record revised	2025-06-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C; Special storage condition: Protect from sunlight and radioactive sources.
Sizes	Total volume 100 to 500 ml

Catalogue Numbers

Catalogue numbers for CaseBioscience®
Catalogue number	Size	Status
APBS-500	Total Volume 500 ml	In distribution
VSOL-100	Total Volume 100 ml	In distribution
MNOL-100	Total Volume 100 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hypure Oil Heavy	Kitazato Corporation	6
FertiCult High Viscosity Oil	Fertipro NV	6
Hypure Oil Light	Kitazato Corporation	6
V-OIL	Vitromed GmbH	4
VitaVitro	Shenzhen VitaVitro Biotech Co., Ltd.	3
Ovoil	Vitrolife Sweden AB	2
ARTSMedia High Viscosity Oil (AM-HV Oil)	AMS Denmark ApS	2
Ovoil Heavy	Vitrolife Sweden AB	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.