Thanks Pang, I see your point. This is the link you provided on 3/5/12: http://www.accessdata.fda.gov/scripts/cd...
That site shows last updated on 3/5/12 with the implication that registration could have been earlier. I think you and I agree that the question still remains whether a premarket notifications have been submitted or not.
It's clear that with the announced significant and positive improvements, the processes have changed over the past few months. If the processes have changed then that would require submittals based upon the new processes. The company has to do whatever it takes to get the necessary approvals given the recent events. As improvements are made in the future, new submissions will probably become necessary per the regs. So this will probably be an ongoing process. But I would like to see the initial ones soon. I would hope they come no later than 6/5/12.
Notification of intent to market need not be filed at the time of establishment registration, but must be submitted at least 90 days prior to marketing. You were likely looking at a summary of the current status of registration, but I believe it was done over a year ago. It is important to realize that registraion is done by the company and need not involve any interaction with the FDA, which may later determine that a device fails to qualify as exempt under 510(k). The latest I heard concerning the notice of intent was the August article reporting that papers would be submitted by the end of last September.
parsgood I am pretty sure it was registered prior to 3/5, but if I recall I actually posted something that showed the UPDATED page as being 3/5.
Not saying that they did or didn't I just remember the page was updated but the content did not change
<<Unfortunatly for him in his excitment to try and Zing me he failed to see that Bret wrote the article unlike the articles coming from Med City news. Oh well sucks being him!!!!!!!>>
Can Bret write in German ?
Lighten up he's not little!!! hahha
Unfortunatly for him in his excitment to try and Zing me he failed to see that Bret wrote the article unlike the articles coming from Med City news. Oh well sucks being him!!!!!!!
<<Sorry Fubar, I was just reminding everyone that you are a worthless little troll with the intelligence of a weiner dog. Sorry for the confusion.>>
You think because you create an insult it's true. You are worse than a troll.
Badbilly wrote<<He's more like my neighbors weiner dog. Pees on the floor, gets smacked with the newspaper and then does it again the next day. Not too intelligent.>>
I only reminded Abig of his own words. Your example isn't even close.
NanoLogix 'advanced culture technology
meets the requirements of the FDA after a
sensitive rapid test. The method yields
reliable data from four to 24 times culture
faster than the conventional cultivation,
depend on bacteria and occupied
Product. The technology enables QA / QSTechnikern,
the growth of micro-colonies
to see much faster and to
identify as traditional Petri dish
Culture, PCR or flow cytometry.
Although the procedure is currently only in two
Standard petri dish sizes available
stands, it is possible in principle, the technology
in corrugated plate arrays for high-throughput
Screening of lead.
"NanoLogix 'advanced culture technology
meets the requirements of the FDA after a
sensitive rapid test." Thanks for the transaltion, abig.
Now that isn't at all misleading! It almost sounds as though the writer is saying the technology has beenn cleared by the FDA, which hasn't happened as far as anyone knows. And this was written by Basrnhizer?
The operating principle
The heart of the BioNanoPore (BNP) method
NanoLogix is of a permeable polymer membrane,
extending between two agar layersis located. The extremely thin, transparent
Figure 3: Principle of the BFN technology from NanoLogix
Membrane allows the microorganisms,
to grow for several hours. Then, after
a fraction of the conventional incubation period,
is the membrane has a F�rbeplatte
transferred. Capillary forces to transport the
Stain - an HRP-conjugated antibody
Solution - through the membrane and bring it in
Contact with the microcolonies. After 10 to 15
Minutes dyeing time, the microcolonies
be detected and identified.
In the testing of a parenteral product,
was found after filtration of the "sterile" solution
with the BioNanoFilter (BFN) technology
a detection sensitivity of one cell per
L with a detection time of four to six
This has the NanoLogix technology, the
Potential production time by shortening
by reducing in-process hold times.
The procedure can be applied to each stage of the
Production process more cost efficient, reliable
and with reasonable throughput
. implement Several scientists,
consider the NanoLogix Technology already
as' new 'gold standard' in the field of