Controls for Blood-Gases, (Assayed and Unassayed)

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Guangdong.

Edan Instruments, Inc. Guangdong, contract manufacturer

How Is JJS Classified?

Controls For Blood-Gases, (Assayed And Unassayed) is FDA product code JJS, Class 1, 21 CFR 862.1660.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2017. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Controls For Blood-Gases, (Assayed And Unassayed)

Autocheck 3+, Level 2, S7345

S7345 AutoCheck 3+, level 2 YELLOW box of 30 ampoules. For ABL7X0

Controls For Blood-Gases, (Assayed And Unassayed)

Catalogue number 10323692, listed by Siemens Healthcare Diagnostics Inc, United States, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Mission Control, Level 1-2-3

For quality control of pH, Blood Gas and Electrolyte Analyzers.

Controls For Blood-Gases, (Assayed And Unassayed)

S7735 Autocheck TM 5+, Level 1

S7735 AutoCheck 5+, level 1 RED box of 30 ampoules. For ABL7XX/8XX

Controls For Blood-Gases, (Assayed And Unassayed)

S7755 Autocheck TM 5+, Level 3

S7755 AutoCheck 5+, level 3 BLUE box of 30 ampoules. For ABL7XX/8XX

Controls For Blood-Gases, (Assayed And Unassayed)

Alinity

IgE Calibrators

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 5+, Level 2

S7740 QUALICHECK5+, level 2 YELLOW box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X

Controls For Blood-Gases, (Assayed And Unassayed)

CueSee® Hyperbaric

CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For…

Controls 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

Controls For Blood-Gases, (Assayed And Unassayed)

Range+ Qualicheck LEV. 3 S7950

Range+ QUALICHECK level 3, box of 30 ampoules for calibration verification

Controls For Blood-Gases, (Assayed And Unassayed)

Rapidqc® Plus Level 3

Catalogue number 10325104, listed by Siemens Healthcare Diagnostics Inc, United States, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Range+ Qualicheck LEV. 1 S7930

Range+ QUALICHECK level 1, box of 30 ampoules for calibration verification

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 4+, Level 1

S7430 QUALICHECK4+, level 1 RED box of 30 ampoules. For ABL300/330, ABL5/50X/555, ABL7X, ABL70X, EML10X, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

Mission Control, Level 3

Catalogue number DD-92003, listed by Diamond Diagnostics Inc., Hungary, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

CueSee® Hyperbaric X-High

CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas…

Controls For Blood-Gases, (Assayed And Unassayed)

CueSee® Hypoxic

CueSee Hypoxic is a quality control liquid used to check blood gas analyzers at critically low oxygen partial pressures. It is intended for professional assessment of analyzer performance…

Controls For Blood-Gases, (Assayed And Unassayed)

S7745 Autocheck TM 5+, Level 2

S7745 AutoCheck 5+, level 2 YELLOW box of 30 ampoules. For ABL7XX/8XX

Controls For Blood-Gases, (Assayed And Unassayed)

Hematocrit S7180 QC Level 2

S7180 QUALICHECK, level 2 Hematocrit and Metabolite - YELLOW box of 30 ampoules. For ABL7x, ABL555, EML105, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

Cleaning Solution With Additive S7375 REF 944-123

S7375 Cleaning Solution 175mL for ABL7XX

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 4+, Level 4

S7460 QUALICHECK4+, level 4 GREEN box of 30 ampoules. For ABL300/330, ABL5/50X/555, ABL7X, ABL70X, EML10X, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

VK-3

Kit of QC material for the validation of sensor linear response in ABL80 Flex series

Controls For Blood-Gases, (Assayed And Unassayed)

Blood Gas and Electrolyte Control

3 catalogue numbers from Level 3, listed by Edan Instruments, Inc., China, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Mission Control, Level 2

Catalogue number DD-92002, listed by Diamond Diagnostics Inc., Hungary, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Phoenix Diagnostics

LiquiCV STAT - Blood Gas / Electrolyte / Metabolite Linearity Control for Abbott iSTAT

Controls For Blood-Gases, (Assayed And Unassayed)

ContrIL Spectrum Control, Level 1

Catalogue number 00009833750, listed by Instrumentation Laboratory SPA, Italy, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

S7765 Autocheck TM 5+, Level 4

S7765 AutoCheck 5+, level 4 GREEN box of 30 ampoules. For ABL7XX/8XX

Controls For Blood-Gases, (Assayed And Unassayed)

Autocheck 3+, Level 3, S7355

S7355 AutoCheck 3+, level 3 BLUE box of 30 ampoules. For ABL7X0

Controls For Blood-Gases, (Assayed And Unassayed)

Range+ Qualicheck LEV. 2 S7940

Range+ QUALICHECK level 2, box of 30 ampoules for calibration verification

Controls For Blood-Gases, (Assayed And Unassayed)

Rapidqc® Plus Level 2

Catalogue number 10341140, listed by Siemens Healthcare Diagnostics Inc, United States, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

ContrIL Spectrum Control, Level 2

Catalogue number 00009833650, listed by Instrumentation Laboratory SPA, Italy, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 4+, Level 3

S7450 QUALICHECK4+, level 3 BLUE box of 30 ampoules. For ABL300/330, ABL5/50X/555, ABL7X, ABL70X, EML10X, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

VKR-5

Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series

Controls For Blood-Gases, (Assayed And Unassayed)

Hematocrit S7170 QC Level 1

S7170 QUALICHECK, level 1 Hematocrit and Metabolite - RED box of 30 ampoules. For ABL7x, ABL555, EML105, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

ContrIL Spectrum Control, Level 3

Catalogue number 00009833850, listed by Instrumentation Laboratory SPA, Italy, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 5+, Level 1

S7730 QUALICHECK5+, level 1 RED box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 4+, Level 2

S7440 QUALICHECK4+, level 2 YELLOW box of 30 ampoules. For ABL300/330, ABL5/50X/555, ABL7X, ABL70X, EML10X, ABL80

Controls For Blood-Gases, (Assayed And Unassayed)

QC Adaptor

QUALICHECK Opener/Adapter for ABL90

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 5+, Level 3

S7750 QUALICHECK5+, level 3 BLUE box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X

Controls For Blood-Gases, (Assayed And Unassayed)

Qualicheck 5+, Level 4

S7760 QUALICHECK5+, level 4 GREEN box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X

Controls For Blood-Gases, (Assayed And Unassayed)

Liquichek

Liquichek Blood Gas Plus CO-Oximeter Control Trilevel MiniPak (An aqueous assayed blood gas, electrolyte, metabolite and CO-Oximeter control.)

Controls For Blood-Gases, (Assayed And Unassayed)

Autocheck 3+, Level 4, S7365

S7365 AutoCheck 3+, level 4 GREEN box of 30 ampoules. For ABL7X0

Controls For Blood-Gases, (Assayed And Unassayed)

Stat Profile

Prime Capillary Tube 230 uL with Balanced Heparin 250 per vial

Controls For Blood-Gases, (Assayed And Unassayed)

Autocheck 3+, Level 1, S7335

S7335 AutoCheck 3+, level 1 RED box of 30 ampoules. For ABL7X0

Controls For Blood-Gases, (Assayed And Unassayed)

Mission Control, Level 1

Catalogue number DD-92001, listed by Diamond Diagnostics Inc., Hungary, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.

Controls For Blood-Gases, (Assayed And Unassayed)

VKR-7

Kit of QC material for the validation of sensor linear response in ABL800 series

Controls For Blood-Gases, (Assayed And Unassayed)

Architect

Quantia Ferritin/Myoglobin/IgE Control

Controls for Blood-Gases, (Assayed and Unassayed)

Who Makes This Device Type in China?

How Is JJS Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies