Roche Molecular Systems, Inc.

CAP 394436 to 394663

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed in the states of GA, CA, NC, and MN.

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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

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.

US-IVD:  Material number 05232880190  Lot Number  R13814, R15785  CE-IVD:   Material Number: 05235898190 05235898190 05235901190 05235910190  Lot Number R15771, R15304

Immunology and Microbiology Devices

3

No

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.

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

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.

Immunology and Microbiology Devices

2

No

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)

COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

Device-associated diagnostic software

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution

DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.