Who else makes this device?

Name: Continuous Single Culture Complete (Cscm-C) with Gentamicin and HSA
Brand: Continuous Single Culture Complete (Cscm-C) with Gentamicin and HSA

Obstetrics & Gynecology › MiscellaneousMedia, Reproductive

Continuous Single Culture Complete (Cscm-C) With Gentamicin and HSA

Continuous Single Culture Complete (CSCM-C) is a novel solution optimized for use in an uninterrupted culture system without dish change or medium renewal. CSCM-C contains Human Serum…

Registry build 21.09.26

Continuous Single Culture Complete (CSCM-C) is a novel solution optimized for use in an uninterrupted culture system without dish change or medium renewal. CSCM-C contains Human Serum Albumin (HSA) and the antibiotic Gentamicin Sulfate.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (3), Shandong (1).

Chinese manufacturers registered for FDA product code MQL
Manufacturer	City	Province	Registered as	Device types
Dongguan King Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Shenzhen VitaVitro Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7
Gimbo Medical Technology Shenzhen Co., Ltd.	Shenzhen	Guangdong	Manufacturer	3
Shandong Wego Ruisheng Medical Device Co., Ltd.	Weihai	Shandong	Manufacturer	2

Record

Regulatory record for Continuous Single Culture Complete (Cscm-C) with Gentamicin and HSA
Listed by	Irvine Scientific LLC, United States
FDA product code	MQL
Device type	Media, Reproductive
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K121572
Record published	2025-06-02
Record revised	2025-06-24 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Continuous Single Culture Complete (Cscm-C) with Gentamicin and HSA
Catalogue number	Size	Status
90165-2x20ML		In distribution

Same Product Code

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LifeGlobal® Media	Coopersurgical, Inc.	27
VitaVitro	Shenzhen VitaVitro Biotech Co., Ltd.	22
Nidacon	Nidacon International AB	19
Sil-Select Plus Lower Layer	Fertipro NV	8
FertiCult Mineral Oil	Fertipro NV	8
Dewin	Donnevie Medical Technology (Shanghai) Co., Ltd.	8
SpermGrad	Vitrolife Sweden AB	8
Sequential Culture Media	Kitazato Corporation	8
Sperm Wash Medium	Invitrocare Inc	7
Enhance-S Plus	Vitrolife Inc.	7

Showing 12 of 360. All products under Media, Reproductive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K160006	2016-05-04

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.