The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
관련기사 - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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모델명 / 제조번호(시리얼번호)
Part Number: A19889, Access APF Wash Buffer REF 81907 Lot Number: 714944, 717432, 720808, 821426, 823659. Part Number: A45144, Access APF Wash Buffer REF A16792 Lot Number: 714939, 717433, 720811, 821429, 823661.
- 의료기기 분류등급
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의료기기 등급
1
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이식된 장치?
No
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유통
Worldwide Distribution-USA (nationwide) and the country of Canada.
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제품 설명
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. || Part Number: A15518, Access 2 APF Wash Buffer REF 81907, || Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
- Manufacturer
- 2 Events
제조사
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제조사 주소
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
- 제조사 모회사 (2017)
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Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 96 건
데이터에 대해 더 자세히 알아보기 여기
biotin interference in total t3, thyroglobulin, free t4 and gi monitor tests used with access imm...
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모델명 / 제조번호(시리얼번호)
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Part Number: 386167; Lot Code: 1201291 & 1201431
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Nationwide & Canada
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제품 설명
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Part Number: 37215, Lot Number: 715293.
- 의료기기 분류등급
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의료기기 등급
3
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이식된 장치?
No
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유통
Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
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제품 설명
Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. || The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Lot Numbers: 715292 and 722462.
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV.
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제품 설명
Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. || The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Lot Numbers 824542 and 825652.
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Zambia.
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제품 설명
Access Immunoassay Systems Total ¿hCG. || The Access Total ¿hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ¿hCG levels in human serum and plasma using the Access Immunoassay Systems.
- Manufacturer