Who else makes this device?

Name: Yumizen C1200 U/CSF L2 Micro Alb Control
Brand: Yumizen C1200 U/CSF L2 Micro Alb Control

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

Yumizen C1200 U/CSF L2 Micro Alb Control

Catalogue number 1300023949, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Yumizen C1200 U/CSF L2 Micro Alb Control
Listed by	Horiba ABX SAS, France
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2020-09-07
Record revised	2025-08-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Yumizen C1200 U/CSF L2 Micro Alb Control
Catalogue number	Size	Status
1300023949		In distribution

Same Product Code

Other products under the same FDA product code
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Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K133676	2014-07-11

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.