Assayed and Unassayed Single (Specified) Analyte Controls Suppliers
Limit companies to: Worldwide USA
Acon Biotech (Hangzhou) Co., Ltd. | Address: 10125 Mesa Rim Road., San Diego 92121, China 
www.aconlab.com.cn | Send Inquiry | Phone: +1-(858)-875-8000
FDA Registration: 9615507
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), Blood Collection Lancet (FDA Code: FMK), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Acon Biotech (Hangzhou) Co., Ltd. provides a broad range of rapid diagnostic and healthcare products. We offer diabetes care, immunoassay, and clinical chemistry, such as urinalysis, urine analyzer, u more...
www.aconlab.com.cn | Send Inquiry | Phone: +1-(858)-875-8000
FDA Registration: 9615507
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), Blood Collection Lancet (FDA Code: FMK), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Acon Biotech (Hangzhou) Co., Ltd. provides a broad range of rapid diagnostic and healthcare products. We offer diabetes care, immunoassay, and clinical chemistry, such as urinalysis, urine analyzer, u more...
AZ Instrument (Shen Zhen) Co., Ltd. | Address: 50, Mei Bao Road, Da Laung Ind. Park, Baoan, Dalang, Baoan, Shenzhen 518109, China
Phone: +886-(4)-253-26668
FDA Registration: 3005257705
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
AZ Instrument (Shen Zhen) Co., Ltd. offers assayed and unassayed single analyte control products, blood collection lancets and over-the-counter blood glucose test systems. more...
Phone: +886-(4)-253-26668
FDA Registration: 3005257705
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
AZ Instrument (Shen Zhen) Co., Ltd. offers assayed and unassayed single analyte control products, blood collection lancets and over-the-counter blood glucose test systems. more...
Andon Health Co., Ltd | Address: 7/F Hua Qiao Chuang Ye Plaza, No: 10 Jin Ping Road, Ya An Street, Nankai District, Tianjin 300193, China
Phone: +86-(22)-60526081
FDA Registration: 3003741676 Quality: ISO 13485:2003, ISO 9001:2000 Certified
Products: Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Electric Therapeutic Massager (FDA Code: ISA), ...
Andon Health Co.,Ltd manufactures health products. Current product line includes blood pressure monitor, blood glucose monitor, tens electronic muscle stimulator, electronic pulse massager, digital mo more...
Phone: +86-(22)-60526081
FDA Registration: 3003741676 Quality: ISO 13485:2003, ISO 9001:2000 Certified
Products: Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Electric Therapeutic Massager (FDA Code: ISA), ...
Andon Health Co.,Ltd manufactures health products. Current product line includes blood pressure monitor, blood glucose monitor, tens electronic muscle stimulator, electronic pulse massager, digital mo more...
Shandong Jiyinsi Electronics Co., Ltd. | Address: Shem-Shun Rd, Korea Industrial, Complex, Manshan Town, Wendeng-City, Shandong-Sheng 264414, China
Products: Intravenous Blood Flowmeter (FDA Code: DPW), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
Shandong Jiyinsi Electronics Co., Ltd. offers a range of medical devices. Our products comprise of electric therapeutic massages, glucose oxidizers, glucose intravenous blood flowmeters, non-invasive more...
Products: Intravenous Blood Flowmeter (FDA Code: DPW), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
Shandong Jiyinsi Electronics Co., Ltd. offers a range of medical devices. Our products comprise of electric therapeutic massages, glucose oxidizers, glucose intravenous blood flowmeters, non-invasive more...
Andon Medical Co., Ltd. | Address: No.04-23-3, Airport Industrial Park, Tianjin, CN-12 300381, China
Phone: +86-(22)-87612426
FDA Registration: 3008573045
Products: Blood Glucose Test Strips, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Andon Medical Co., Ltd. deals with blood glucose test systems. more...
Phone: +86-(22)-87612426
FDA Registration: 3008573045
Products: Blood Glucose Test Strips, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Andon Medical Co., Ltd. deals with blood glucose test systems. more...
Zhangmutou Yi Jian Dian Zi Factory | Address: Yin Yang Industrial Estate, Zhang Yang, Zhangmutou, Dongguan, Guang Dong, China
Phone: +86-(852)-22458188
Products: Manual Stethoscope (FDA Code: LDE), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Zhangmutou Yi Jian Dian Zi Factory focuses on assayed and unassayed single analyte controls and counter blood glucose test systems. We also use manual stethoscopes. more...
Phone: +86-(852)-22458188
Products: Manual Stethoscope (FDA Code: LDE), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Zhangmutou Yi Jian Dian Zi Factory focuses on assayed and unassayed single analyte controls and counter blood glucose test systems. We also use manual stethoscopes. more...
Apex Biotechnology Corp. | Address: NO.7, Li-Hsin Road.V, Hsin-Chu science park, Hsin-Chu, Taiwan, China
www.apexbio.com | Send Inquiry | Phone: +886-(3)-5641952
FDA Registration: 9616936
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Lactic Acid Enzymatic Method (FDA Code: KHP), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Non-Powered Traction Apparatus (FDA Code: HST), ...
Apex Biotechnology Corp. specializes in developing biosensor-based blood glucose monitoring system. Our product line includes multi-functional monitoring system, blood glucose monitoring system, blood more...
www.apexbio.com | Send Inquiry | Phone: +886-(3)-5641952
FDA Registration: 9616936
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Lactic Acid Enzymatic Method (FDA Code: KHP), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Non-Powered Traction Apparatus (FDA Code: HST), ...
Apex Biotechnology Corp. specializes in developing biosensor-based blood glucose monitoring system. Our product line includes multi-functional monitoring system, blood glucose monitoring system, blood more...
Ind Diagnostic Inc | Address: 1629 Fosters Way, Delta, British Columbia V3M 6S7, Canada 
www.ind.ca | Send Inquiry | Phone: +1-(604)-522-1619
Products: Ovulation (Luteinizing Hormone) Test Kits, Gonorrhea Test Kits, Swabs, Gonorrhea Test Kits, Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), ...
Ind Diagnostic Inc. is a biotechnology company that specializes in research, development and manufacturing of advanced in-vitro diagnostic (IVD) test systems. We are accredited with ISO9001 & ISO13485 more...
www.ind.ca | Send Inquiry | Phone: +1-(604)-522-1619
Products: Ovulation (Luteinizing Hormone) Test Kits, Gonorrhea Test Kits, Swabs, Gonorrhea Test Kits, Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), ...
Ind Diagnostic Inc. is a biotechnology company that specializes in research, development and manufacturing of advanced in-vitro diagnostic (IVD) test systems. We are accredited with ISO9001 & ISO13485 more...
Btnx, Inc. | Address: 570 Hood Road, Unit 23, Markham, Ontario L3R 4G7, Canada
www.btnx.com | Phone: +1-(905)-9449565, 888 339 9964
FDA Registration: 3003917514 Quality: ISO 13485, ISO 9001 Certified
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Alkaline Phosphatase Isoenzymes Electrophoretic Separation Test (FDA Code: CIN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB), ...
Btnx, Inc. is a biotechnology company. We provide rapid, point-of-care diagnostics. We develop and manufacture advanced in-vitro diagnostic (IVD) tests and information technology systems to manage poi more...
www.btnx.com | Phone: +1-(905)-9449565, 888 339 9964
FDA Registration: 3003917514 Quality: ISO 13485, ISO 9001 Certified
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Alkaline Phosphatase Isoenzymes Electrophoretic Separation Test (FDA Code: CIN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB), ...
Btnx, Inc. is a biotechnology company. We provide rapid, point-of-care diagnostics. We develop and manufacture advanced in-vitro diagnostic (IVD) tests and information technology systems to manage poi more...
Glucoplus Inc | Address: #2323, Halpern, Saint-Laurent, Quebec H4S1S3, Canada
www.glucoplus.ca | Send Inquiry | Phone: +1-(215)-815-0897
FDA Registration: 3005739604
Products: Blood Glucose Monitoring Systems, Automated Blood Sampler, Diabetes Test Strips, Blood Sample Collection Kits, Testing Strips, Blood Glucose Monitor Kit, ...
Glucoplus Inc manufactures diabetic and homecare products. Our product line comprises of blood glucose monitor, test strips, control solution, lancing device and check strips. Our test strips are desi more...
www.glucoplus.ca | Send Inquiry | Phone: +1-(215)-815-0897
FDA Registration: 3005739604
Products: Blood Glucose Monitoring Systems, Automated Blood Sampler, Diabetes Test Strips, Blood Sample Collection Kits, Testing Strips, Blood Glucose Monitor Kit, ...
Glucoplus Inc manufactures diabetic and homecare products. Our product line comprises of blood glucose monitor, test strips, control solution, lancing device and check strips. Our test strips are desi more...
Flextronics International Gmbh | Address: Friesacher Strasse 3, Althofen A-9330, Austria
Phone: +43-(978)-2355643
FDA Registration: 3006126537
Products: Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Catheter Stylets (FDA Code: DRB), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Instruments (FDA Code: KNW), Anesthetic Infusion Pump (FDA Code: FRN), ...
Flextronics International Gmbh focuses on blood lancets. more...
Phone: +43-(978)-2355643
FDA Registration: 3006126537
Products: Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Catheter Stylets (FDA Code: DRB), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Instruments (FDA Code: KNW), Anesthetic Infusion Pump (FDA Code: FRN), ...
Flextronics International Gmbh focuses on blood lancets. more...
Ok Biotech Co., Ltd. | Address: 4F-1, No.83, Sec.2, Gongdao 5th Rd, Hsinchu City 30070, Afghanistan
www.okbiotech.com | Phone: +886-(3)-5160258
FDA Registration: 3005862821
Products: Blood Glucose Meters, Blood glucose testing, Blood Collection Lancet (FDA Code: FMK), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), ...
Ok Biotech Co., Ltd. manufactures glucose meters. We supply glucose meters that include Okmeter glucose meter, match glucose meter, link blood glucose meter and direct blood glucose meter. Our glucose more...
www.okbiotech.com | Phone: +886-(3)-5160258
FDA Registration: 3005862821
Products: Blood Glucose Meters, Blood glucose testing, Blood Collection Lancet (FDA Code: FMK), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), ...
Ok Biotech Co., Ltd. manufactures glucose meters. We supply glucose meters that include Okmeter glucose meter, match glucose meter, link blood glucose meter and direct blood glucose meter. Our glucose more...
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FDA Code / Regulation: JJX / 862.1660
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.
