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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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i-STAT - 00054749004966

I-STAT TBI Control L1
ABBOTT POINT OF CARE INC.
06P17-25
In Commercial Distribution

  • 00054749004966 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT hs-TnI Control Level 3 - 00054749004942

i-STAT hs-TnI Control Level 3
Abbott Point of Care Inc.
06P17-23
In Commercial Distribution

  • 00054749004942 ()
06P17-23

  • Troponin I IVD, control

i-STAT hs-TnI Control Level 1 - 00054749004928

i-STAT hs-TnI Control Level 1
Abbott Point of Care Inc.
06P17-21
In Commercial Distribution

  • 00054749004928 ()
06P17-21

  • Troponin I IVD, control

i-STAT - 00054749004973

I-STAT TBI Control L2
ABBOTT POINT OF CARE INC.
06P17-26
In Commercial Distribution

  • 00054749004973 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT - 00054749004959

I-STAT TBI Calibration Verification Set
ABBOTT POINT OF CARE INC.
06P17-24
In Commercial Distribution

  • 00054749004959 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT hs-TnI Control Level 2 - 00054749004935

i-STAT hs-TnI Control Level 2
Abbott Point of Care Inc.
06P17-22
In Commercial Distribution

  • 00054749004935 ()
06P17-22

  • Troponin I IVD, control

i-STAT hs-TnI Calibration Verification, Levels 1-3 - 00054749004911

i-STAT hs-TnI Calibration Verification, Levels 1-3
Abbott Point of Care Inc.
06P17-20
In Commercial Distribution

  • 00054749004911 ()
06P17-20

  • Troponin I IVD, control

MedTest DX HCG Control Set Level B - 00817439020857

HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLB
In Commercial Distribution

  • 00817439020857 ()
HCG-CTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX Elevated HCG Control Vial Label - B - 00817439020840

Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLB
In Commercial Distribution

  • 00817439020840 ()
HCGCTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX HCG Control Set Level A - 00817439020833

HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLA
In Commercial Distribution

  • 00817439020833 ()
HCG-CTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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