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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PTH (Intact, 1-84) ELISA - B24221IPTHUE010

The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
21-IPTHU-E01
In Commercial Distribution

  • B24221IPTHUE010 ()
21-IPTHU-E01

  • Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)

Adrenocorticotropic Hormone ELISA - B24221ACTHUE010

The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
21-ACTHU-E01
In Commercial Distribution

  • B24221ACTHUE010 ()
21-ACTHU-E01

  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

Cellfina Motor Module Device and Package - 00840763100384

No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution

  • 00840763100384 ()


  • Mechanical skin contouring system motor

V. Mueller - 10885403047626

V. Mueller MEDIUM OPTICARE SCOPE TRAY HOLDS ONE SCOPE 1-10MM IN DIAMETER AND 15 1/2" IN LENGTH 15.5X2.75X1.38" (394X70X35MM)
CAREFUSION 2200, INC
GP3-3170
Not in Commercial Distribution

  • 10885403047626 ()
GP3-3170

  • Device sterilization/disinfection container, reusable

HCY - 05055273208894

A homocysteine test system is a device intended for the quantitative in vitro determination of homocysteine concentration in human serum.
RANDOX LABORATORIES LIMITED
HY4036
In Commercial Distribution

  • 05055273208894 ()
HY4036

  • Homocysteine IVD, reagent

AST - 05055273208245

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS8306
In Commercial Distribution

  • 05055273208245 ()
AS8306

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

MDONE - 05055273208092

The Methadone assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine.
RANDOX LABORATORIES LIMITED
DA4016
In Commercial Distribution

  • 05055273208092 ()
DA4016

  • Methadone IVD, reagent

EtOH - 05055273208085

The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum.
RANDOX LABORATORIES LIMITED
DA4015
In Commercial Distribution

  • 05055273208085 ()
DA4015

  • Ethanol (ETOH) IVD, reagent

MDMA - 05055273208078

The MDMA assay is an in vitro diagnostic reagent. For the qualitative and semi-quantitative analysis of MDMA in human urine.
RANDOX LABORATORIES LIMITED
DA4014
In Commercial Distribution

  • 05055273208078 ()
DA4014

  • Amphetamine/methamphetamine group IVD, reagent

OPIAT - 05055273208054

The Opiates assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Opiates in human urine.
RANDOX LABORATORIES LIMITED
DA4012
In Commercial Distribution

  • 05055273208054 ()
DA4012

  • Opiate/opiate metabolite IVD, reagent
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