21342 | 2420240403, 2420303403

IVD: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

ivd

Catalog Number: 21342 Batch Number: viz FSN

Diagnostic medical devices in vitro

Immunology and Microbiology Devices

Medical Device Safety Alert: BioMerieux VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards

All lot numbers

Immunology and Microbiology Devices

2

No

There was no U.S. distribution as the cards were for export only to Canada and Sweden.

VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

All lot numbers

Immunology and Microbiology Devices

2

No

There was no U.S. distribution as the cards were for export only to Canada and Sweden.

VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N182, REF 410 804, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N181, REF 410 803, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France. || Cards that are intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N180, REF 410 771, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France..

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N179, REF 410 640, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France. || Cards that are intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N177, REF 410 392, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N176, REF 410 402, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N175, REF 410 403, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N174, REF 410 404, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N170, REF 410 222, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N168, REF 410 139, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N166, REF 410 136, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N165, REF 410 102, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N164, REF 410 101, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

All lot numbers

Immunology and Microbiology Devices

2

No

Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.

VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.