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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Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems Rubella IgM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374044
Not in Commercial Distribution

  • 00630414971582 ()
LKRM1(D)

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
fPS Free PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374043
In Commercial Distribution

  • 00630414971575 ()
LKPF1(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
HBS HBsAg Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374038
Not in Commercial Distribution

  • 00630414971551 ()
LKHB1(D)

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Toxoplasma IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374023
In Commercial Distribution

  • 00630414971483 ()
L2KTM2(D)

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Rubella IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374021
In Commercial Distribution

  • 00630414971469 ()
L2KRM2(D)

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HBS HBsAg Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374014
In Commercial Distribution

  • 00630414971438 ()
L2KHB2(D)

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control
Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Anti-TPO CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373708
In Commercial Distribution

  • 00630414971407 ()
LTOCVM

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
Troponin I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373707
In Commercial Distribution

  • 00630414971391 ()
LTICVM

  • Troponin I IVD, control
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
TBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373705
In Commercial Distribution

  • 00630414971377 ()
LTBCVM

  • Thyroxine binding globulin (TBG) IVD, control
Total T3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373704
In Commercial Distribution

  • 00630414971360 ()
LT3CVM

  • Total triiodothyronine (TT3) IVD, control
Free PSA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373702
In Commercial Distribution

  • 00630414971346 ()
LPFCVM

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
C-Peptide CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373701
In Commercial Distribution

  • 00630414971339 ()
LPEPCVM

  • C-peptide IVD, control
Pyrilinks-D CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373700
In Commercial Distribution

  • 00630414971322 ()
LPDCVM

  • Cyclic adenosine monophosphate (cAMP) IVD, control
PAP CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373699
In Commercial Distribution

  • 00630414971315 ()
LPACVM

  • Prostatic acid phosphatase (PAP) IVD, control
CA 125 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373698
In Commercial Distribution

  • 00630414971308 ()
LOPCVM

  • Cancer antigen 125 (CA125) IVD, control
Myoglobin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373696
In Commercial Distribution

  • 00630414971292 ()
LMYCVM

  • Myoglobin IVD, control
Albumin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373693
In Commercial Distribution

  • 00630414971261 ()
LHACVM

  • Albumin IVD, control
IGFBP-3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373692
In Commercial Distribution

  • 00630414971254 ()
LGBCVM

  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control
Free T4 CVM - IMMULITE -
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373691
In Commercial Distribution

  • 00630414971247 ()
LFT4CVM

  • Free thyroxine (FT4) IVD, control
Folate Acid CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373690
In Commercial Distribution

  • 00630414971230 ()
LFOCVM

  • Folate (vitamin B9) IVD, control
Estradiol CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373688
In Commercial Distribution

  • 00630414971216 ()
LE2CVM

  • Estradiol (oestradiol) (E2) IVD, control
CRP (High Sensitivity) CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373686
In Commercial Distribution

  • 00630414971193 ()
LCRPCVM

  • C-reactive protein (CRP) IVD, control
Calcitonin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373685
In Commercial Distribution

  • 00630414971186 ()
LCLCVM

  • Procalcitonin (PCT) IVD, control
CEA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373684
In Commercial Distribution

  • 00630414971179 ()
LCECVM

  • Carcinoembryonic antigen (CEA) IVD, control
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