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About KGT

  • Birthday 04/21/1976

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  1. Looking for some info on guidance's or regulations if anyone can point my in the right direction on the following: Is it acceptable if you have a BECS that has a public facing API? Essentially making it an "open" system for data transfer over the internet, or does there need to be some time kind of intermediary system or device in place acting as a kind of "proxy" that prevents direct access to the BECS db? Thanks!
  2. Does any know of a cordless barcode scanner that will scan both codabar and ISBT 128 barcodes?
  3. Yes you would own the product and you can do what ever you want with it, convert, divide, the "Further Processed by" info is then generated on in the lower right of the label I was just curious if there was any regs or guidance on additional antigen testing for purchased products specifically for labeling.
  4. Hello, is anyone aware of any regulation that would prohibit a facility from importing a product and then performing additional reference testing on it and having the antigen codes print on the 4x4 full face label? Or can this only be accomplished with in-house products.
  5. KGT


    Does anyone know or anyone use any scales for weighing products that has a data port (or keyboard wedge connection, like barcode scanners) that can capture and send that weight value to the computer?
  6. Hello, just wondering if anyone has been dealing with 10 digit FDA registration numbers during labeling of codabar or ISBT products and is there a spec out there detailing this information.
  7. We are a software company that has acquired a 510k-cleared software device that we do plan to market to others.
  8. I have a question that maybe someone can point me in the right direction. If a company acquires a 510k cleared software devices and they want to change the name of the original software to reflect the new company's name is there a regulation that describes this process or any forms that need to be completed and submitted? Thank You.
  9. Hello, The US Consensus Standard for the Uniform Labeling of Blood and Blood Components v3.0.0 draft H (April 2009) in section 7.6 page 93 lists the testing code as "N0008" and the description as "Negative for antibodies to CMV". Your original post indicated your description as "eye readable description of "Negative to antibodies to CMV". Hope that helps.
  10. Hello everyone I have a question about labeling pooled products. Does anyone know if the pooled ABO codes (i.e. A0, B0, C0, D0, E0, F0, G0, H0) are the only blood type codes that are permitted to be used with pooled product codes? For example could you label a pooled product E3833 with a standard blood type of AP (code- 62)? Any help would be appreciated. Thank You.
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