FDA.report

ELITechGroup Inc

Matched from indexed company URL: ELITECHGROUP INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
17179661717966ELITechGroup Inc1Y2026-01-01370 West 1700 South LOGAN UT US 84321
30035402363003540236ELITechGroup MDX LLC.1Y2026-01-0121720 23rd Dr SE, Suite 150 Bothell WA US 98021
30443203593044320359ELITechGroup Inc., Tucson1N2026-01-013950 S. Country Club Rd. Suite #470, L Tucson AZ US 85714

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
03661540300035Microsed-System® Automated ESR Analyzer - The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.(800) 453 2725service.ebs@elitechgroup.com
03661540300042Mix-Rate® X20 Automated ESR Analyzer - The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.(800) 453 2725service.ebs@elitechgroup.com
03661540300202Monosed® ESR Vacuum Tubes, Carton - ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).(800) 453 2725service.ebs@elitechgroup.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
328021165302587K863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERCGZ1988-05-24
328022065332837K853973WESCOR MODEL 3700 WEBSTER SWEAT INDUCERKTB1985-10-16
3493621313462725K240854Accelerate Arc SystemQNJ2024-09-26
328022043695790K180627Macroduct Advanced Model 3710KTB2018-07-27
1089821764419289K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI2018-10-29
1089821536595845K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWARENQX2013-10-17
328021345106223K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICJFS2013-03-27
1089821175636932K112937MRSA/SA ELITE MGBNQX2012-06-01
1089821397365503K083430REAL-TIME PCR INTERNAL CONTROL 2B SETOLD2009-01-15
328021202784444K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERJIS2003-10-21
328021205576649K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
328021711617286K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMKTB2001-03-20
328021070327260
328021926202927
1089822031134576
328021105972696
328021118086861
328021127690770
328021143812424
328021230867168
328021234347663
328021235547482
328021275132654
328021363330821
328021373199278
328021422949660
328021617128577
1089821743020633
328021847821436
328021898370667
1089821915549129
328021936648840
1089821946864853
328022031134576
328022041971128

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KTB32018-07-27
NQX22013-10-17
QNJ12024-09-26
PGI12018-10-29
JFS12013-03-27
OLD12009-01-15
JIS12003-10-21
LCP12003-08-06
CGZ11988-05-24

PMN

GUDID

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