Who else makes this device?

Name: High Metabolite QC, Level 1
Brand: High Metabolite QC, Level 1

Clinical Chemistry › Test SystemsControls For Blood-Gases, (Assayed And Unassayed)

High Metabolite QC, Level 1

S7570 QUALICHECK, level 1 High Metabolite - RED box of 30 ampoules. For ABL520/555, ABL7XX, EML105, NPT7

Registry build 21.09.26

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JJS
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for High Metabolite QC, Level 1
Listed by	Radiometer Medical APS, Denmark
FDA product code	JJS
Device type	Controls For Blood-Gases, (Assayed And Unassayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2022-12-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning – May cause an allergic reaction.; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for High Metabolite QC, Level 1
Catalogue number	Size	Per pack	Status
944-099		30	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	16
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	11
Architect	Abbott Laboratories	7
Stat Profile	Nova Biomedical Corporation	7
Blood Gas and Electrolyte Control	Edan Instruments, Inc.	3
VKR-7	Radiometer America, Inc.	1
Mission Control, Level 1	Diamond Diagnostics Inc.	1
Autocheck 3+, Level 1, S7335	Radiometer Medical APS	1
Autocheck 3+, Level 4, S7365	Radiometer Medical APS	1
Qualicheck 5+, Level 4	Radiometer Medical APS	1
Qualicheck 5+, Level 3	Radiometer Medical APS	1
QC Adaptor	Radiometer Medical APS	1

Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150226	2015-05-13
K130415	2013-03-26
K130236	2013-03-15

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.