Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

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Medical diagnostics laboratories perform various types of testing, including point-of-care testing. At least in the United States, the [[Clinical Laboratory Improvement Amendments]] (CLIA) test complexities, as determined by the U.S. Food & Drug Administration (FDA)<ref name="FDA_CLIA18">{{cite web |url=https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations |title=CLIA Categorizations |author=U.S. Food & Drug Administration |date=25 February 2020 |accessdate=18 November 2021}}</ref>, and resulting public CLIA Database provide insight into the instrumentation and equipment vendors marketing equipment for diagnostic and research laboratories. While not a complete list of instrument and equipment vendors, the CLIA-approved vendor lists below make an excellent starting point for laboratories seeking to add to its testing inventory.
As previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:


The following two tables list vendors verified to sell CLIA-waived instruments and/or test kits. CLIA-waived instruments and test kits are deemed as being simple to use and as having little chance in providing wrong [[information]] or harming someone. The vendors were pulled from the FDA's [https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data downloadable CLIA file] from November 2021. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.
* [https://www.abacusdiagnostica.com/ Abacus Diagnostica Oy]
* [https://www.zeiss.com/meditec/int/home.html Carl Zeiss Meditec AG]
* [https://www.clonit.it/en/ Clonit SRL]
* [https://www.devyser.com/ Devyser AB]
* [https://www.diapro.it/ Dia.Pro Diagnostic Bioprobes Srl]
* [https://en.dynamiker.com/ Dynamiker Biotechnology (Tianjin) Co., Ltd.]
* [https://www.dynextechnologies.com/ Dynex Technologies, Inc.]
* [https://www.lifehealthmed.com/ EasyDx, Inc.]
* [http://entrogen.com/ EntroGen, Inc.]
* [https://www.eppendorf.com/US-en/ Eppendorf AG]
* [https://www.hitachi-hightech.com/global/ Hitachi High-Technologies Corporation]
* [http://www.htz.biz/index.htm HTZ Ltd.]
* [http://www.humasis.com/en/ Humasis Co., Ltd.]
* [https://www.virion-serion.de/en/ Institut Virion\Serion GmbH]
* [https://www.jeolusa.com/ JEOL USA, Inc.]
* [https://www.launchdiagnostics.com/ Launch Diagnostics Ltd.]
* [https://www.mt.com/us/en/home.html Mettler-Toledo International, Inc.]
* [http://www.mkldiagnostics.com/ MKL Diagnostics AB]
* [https://www.healthcare.nikon.com/en/ Nikon Corporation]
* [https://www.novatec-id.com/ NovaTec Immundiagnostica GmbH]
* [https://medical.olympusamerica.com/ Olympus Corporation of the Americas]
* [https://www.orgentec.com/en/ ORGENTEC Diagnostika GmbH]
* [https://www.pentaxmedical.com/ PENTAX Europe GmbH]
* [https://www.sartorius.com/ Sartorius AG]
* [https://www.shimadzu.com/ Shimadzu Corporation]
* [https://en.vircell.com/ Vircell SL]
* [https://www.waters.com/ Waters Corporation]


'''Note''': Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are CLIA-certified as moderate or complex, as well as a variety of other non-CLIA-certified solutions. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.
Also, see BioPharmGuy's [https://biopharmguy.com/links/company-by-location-diagnostics.php worldwide diagnostics companies, by location].
{{Vendors of CLIA-waived items}}
 
The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits. The same methodology was used as above for CLIA-waived, with the exception of opting to not provide specifics about instrument and test types.
 
'''Note''': Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.
{{Vendors of CLIA-certified moderate or complex items}}
 
==References== 
{{Reflist}}

Revision as of 01:00, 22 January 2022

As previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:

Also, see BioPharmGuy's worldwide diagnostics companies, by location.

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