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M-I-03-18: IDEXX Transition to the New SNAP. Beta-lactam Test Kit

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HHS:PHS:FDA:CFSAN:OC:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-03-18

December 19, 2003

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: IDEXX Transition to the New SNAP. Beta-lactam Test Kit

Below is the text of a letter received by FDA from Larry Chaney, Ph.D., Dairy Business Manager, IDEXX Laboratories, Inc.

"Based on FDA's approval of the transition to New SNAP. Beta-lactam test kits, IDEXX Laboratories, Inc. will manage the inventory of the remaining SNAP Beta-lactam product based on the customer's demand in an expeditious manner. As you may be aware, the product is available in both 20 test and 100 test kit quantities. While we will attempt to completely deplete the inventory of current product, it may be necessary to sell New SNAP. Beta-lactam based on customer's test kit quantity demand, creating a limited amount of time that the two products will be sold.

Once the inventory of SNAP Beta-lactam product has been depleted from our inventory, SNAP Beta-lactam test kits will no longer be sold in the United States. Once the expiration date of the SNAP Beta-lactam test kit has been reached, this product will no longer be an acceptable test for regulatory use.

The attached file has the lot numbers and the associated expiration dates for SNAP Beta-lactam test kits. The expiration date of 7 July 2004 will be the last date that SNAP Beta-lactam test kit and the SNAP Image reader will be acceptable for regulatory use."

Based on the information provided in this letter, the next update of M-a-85 will contain a date of 7 July 2004 as the last date that the current SNAP Beta-lactam, both the visual and instrumental reading, can be used for NCIMS testing. It will also be the last date that the SNAP Image Reader can be used for regulatory testing as it is not approved for use with the New SNAP. Beta-lactam product.

Below is the file as cited in the text of the letter:

SNAP Beta-lactam Test Kits

Lot #"Expiration Date"
249AY25-Nov-03
354AY28-Nov-03
516BY12-Dec-03
535BY19-Dec-03
573BY21-Dec-03
459BY8-Jan-04
137DY15-Jan-04
825CY18-Jan-04
603CY22-Jan-04
696CY28-Jan-04
800CY23-Feb-04
801CY2-Mar-04
190DY19-Mar-04
399EY25-Mar-04
222DY8-Apr-04
543EY21-Apr-04
660FY18-May-04
522HY26-May-04
706FY2-Jun-04
916GY9-Jun-04
510HY24-Jun-04
628HY07-Jul-04

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Milk Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the FDA Web site at http://www.fda.gov/food at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@cfsan.fda.gov.

/s/

CAPT Robert F. Hennes, RS, MPH, Chief
Milk Safety Branch