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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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AST - 05055273200430

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS1267
In Commercial Distribution

  • 05055273200430 ()
AS1267

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

AST - 05055273200423

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS1204
In Commercial Distribution

  • 05055273200423 ()
AS1204

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

AST - 05055273200416

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS1202
In Commercial Distribution

  • 05055273200416 ()
AS1202

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

LimFlow V-Ceiver - 00850041730141

The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
Limflow Inc.
VC-US-23
In Commercial Distribution

  • 00850041730141 ()


  • Intravascular extraction catheter-snare

LimFlow V-Ceiver - 00850041730004

The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
Limflow Inc.
VC-US-21
In Commercial Distribution

  • 00850041730004 ()


  • Intravascular extraction catheter-snare

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)

Pointe Scientific, Inc. - 00811727011336

Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control

Pointe Scientific, Inc. - 00811727013903

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 30 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-30
In Commercial Distribution

  • 00811727013903 ()
13-B7552-R2-30

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013897

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 125 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-125
In Commercial Distribution

  • 00811727013897 ()
13-B7552-R2-125

  • Urea IVD, kit, enzyme spectrophotometry
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