Approvals

Definitions

"Approved"
The registration of the product has been approved by the appropriate authority in a given country.

"Cleared"
FDA has agreed that the product is substantially equivalent to a device already legally marketed in the U.S. (per section 510(k)); therefore the product is available for promotion and sale in the U.S. This applies to the U.S. only.

"Marketable"
Product can be promoted and is available for sale; specific to countries where no formal regulatory approval process exists for given product.

 

 

Products

1. PROCLEIX^® Assays

1.1 PROCLEIX^® HIV-1/HCV Assay

1.2 PROCLEIX^® ULTRIO Plus^™ Assay

1.3 PROCLEIX^® ULTRIO^® Assay

1.4 PROCLEIX^® ULTRIO^® ABD

1.5 PROCLEIX^® WNV Assay

 

2. PROCLEIX^® Instruments

2.1 PROCLEIX^® System

2.2 PROCLEIX^® TIGRIS^® System

2.3 PROCLEIX^® OPTIVA^™ FEP

2.4 PROCLEIX^® OPTIVA^™ RAS

2.5 PROCLEIX^® OPTIVA^™ Assay Software

 

3. PROCLEIX^® Software

3.1 PROCLEIX^® OPTIVA^™ Pooling Software

3.2 PROCLEIX^® CPT Pooling Software

3.3 PROCLEIX^® NAT TRACKER^® Software

 

4. RIBA

4.1 Chiron RIBA HCV 2.0 SIA

4.2 Chiron RIBA HCV 3.0 SIA (Automated)

4.3 Chiron RIBA HCV 3.0 SIA (Manual)

4.4 Chiron RIBA HIV-1/HIV-2 SIA (Automated)

4.5 Chiron RIBA HIV-1/HIV-2 (Manual)

 

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