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Devices
UniCel Dxl 800 Access lmmunoassay System
모델명 / 제조번호(시리얼번호)
Part Number 973100; Serial Numbers: 600469, 601097, 601098, 601144, 601182, 601160, 601188, 601071, 601117, 601114, 601137, 601059, 601039, 601099, 601088, 601176, 601184, 601178, 601025, 601186, 601110, 601063, 601002, 601029, 601133, 601106, 601215, 601159, 601077, 601202, 601206, 601079, 601051, 601179, 601130, 601058, 601031, 601212, 601173, 601028, 601078, 601094, 601210, 601189, 601228, 601043, 601092, 601171, 601026, 601122, 601208, 601103, 601089, 601108, 601183, 600933 600971, 600919, 600910, 600904, 600935, 601005, 600977, 600936, 600993, 600965, 601011, 600957, 600918, 601015, 600992, 600905, 600914, 600947, 601016, 601013, 600981, 600903, 600949, 601012, 600983, 600970, 600912, 601004, 600915, 600907, 600987, 600939, 600996, 601007, 600899, 601006, 600938, 600952, 600988, 601020, 600928, 600937, 600972, 955056, 965059, 954609, 949471, 954490, 501442, and 499300.
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide and Canada
제품 설명
Beckman Coulter UniCel Dxl 800 Access Immunoassay System; || Part Number: 973100 || With: UniCel Dxl 800 Modification (MOD ID 10027) || and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.
Manufacturer
Beckman Coulter Inc
1 Event
UniCel Dxl 800 Access lmmunoassay System 의 리콜
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제조사
Beckman Coulter Inc
제조사 주소
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
Source
USFDA
Language
English
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