Roche Molecular Systems, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 21 건

  • 모델명 / 제조번호(시리얼번호)
    CAP 394436 to 394663
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of GA, CA, NC, and MN.
  • 제품 설명
    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 || Automated sample processing instrument used with CAP/CA and CAP/CTM. || Roche Molecular Systems, Inc. || 1080 US Highway 202 South || Branchburg, NJ 08876 || USA || Made in Switzerland
  • 모델명 / 제조번호(시리얼번호)
    K110923  cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier  cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884)  IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    cobas¿ PCR Urine Kit 100 PKT IVD || cobas¿ PCR Female Swab Kit 100 PKT IVD || cobas¿ PCR media 100T IVD || cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD || Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA || Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 || The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.
  • 모델명 / 제조번호(시리얼번호)
    US-IVD:  Material number 05232880190  Lot Number  R13814, R15785  CE-IVD:   Material Number: 05235898190 05235898190 05235901190 05235910190  Lot Number R15771, R15304
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK.
  • 제품 설명
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD || Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA || Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA || The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula
  • 모델명 / 제조번호(시리얼번호)
    Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
  • 제품 설명
    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
  • 모델명 / 제조번호(시리얼번호)
    Device-associated diagnostic software
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
하나 더 16 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA
하나 더 3 건 더