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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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No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD
No Description
Bio/Data Corporation
100994
In Commercial Distribution

  • G0561009940 ()
100994

  • Saline sodium citrate buffer IVD
No Description
Bio/Data Corporation
100991
In Commercial Distribution

  • G0561009910 ()
100991

  • Buffered isotonic saline reagent IVD
The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-IGEHU-E01
Not in Commercial Distribution

  • B24225IGEHUE010 ()
25-IGEHU-E01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
For the quantitative measurement of Luteinizing Hormone (LH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.
Diagnostics Biochem Canada Inc
CAN-LH-4040
In Commercial Distribution

  • B261CANLH40400 ()
CAN-LH-4040

  • Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)
For the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.
Diagnostics Biochem Canada Inc
CAN-GH-4070
In Commercial Distribution

  • B261CANGH40700 ()
CAN-GH-4070

  • Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA)
For the quantitative measurement of Dehydroepiandrosterone Sulfate (DHEAS) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.
Diagnostics Biochem Canada Inc
CAN-DHS-480
In Commercial Distribution

  • B261CANDHS4800 ()
CAN-DHS-480

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)
The ALPCO C-peptide ELISA is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CPTHU-E01.1
In Commercial Distribution

  • B24280CPTHUE010 ()
80-CPTHU-E01.1

  • C-peptide IVD, kit, enzyme immunoassay (EIA)
The Pancreatic Elastase ELISA is intended for the quantitative determination of pancreatic elastase in human stool samples. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
30-PANHU-E01
In Commercial Distribution

  • B24230PANHUE010 ()
30-PANHU-E01

  • Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)
IM1 AL -US is a dental insert for initial osteotomy in extractions sites to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
IM1 AL -US
In Commercial Distribution

  • E322035100101010 ()
03510010-101

  • Dental ultrasonic surgical system handpiece tip
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