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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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P AMY - 05055273200669

The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.
RANDOX LABORATORIES LIMITED
AY7934
In Commercial Distribution

  • 05055273200669 ()
AY7934

  • Amylase isoenzyme IVD, reagent

AMY - 05055273200577

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1582
Not in Commercial Distribution

  • 05055273200577 ()
AY1582

  • Amylase isoenzyme IVD, reagent

AMY - 05055273200560

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1580
In Commercial Distribution

  • 05055273200560 ()
AY1580

  • Amylase isoenzyme IVD, reagent

ALS CAL - 05055273200089

The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189.
RANDOX LABORATORIES LIMITED
AD5000
In Commercial Distribution

  • 05055273200089 ()
AD5000

  • Aldolase IVD, calibrator

QuPID® hCG - 00657498122020

For the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
STANBIO LABORATORY, L.P.
1220-050
In Commercial Distribution

  • 00657498122020 ()
  • 00657498122044 ()
1220-050

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

QuPID® hCG - 00657498122013

For the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
STANBIO LABORATORY, L.P.
1220-025
In Commercial Distribution

  • 00657498122013 ()
  • 00657498122037 ()
1220-025

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Direct Glycohemoglobin (HbA1c) Calibrator Set - 00657498000885

For use as a calibrator in the quantitative determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay.
STANBIO LABORATORY, L.P.
0365-401
In Commercial Distribution

  • 00657498000885 ()
0365-401

  • Glycated haemoglobin (HbA1c) IVD, calibrator

CariFree Fluoride Varnish - 00856596006410

A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Dental Alliance Holdings LLC
Raspberry
Not in Commercial Distribution

  • 00856596006410 ()


  • Dental cavity varnish

CariFree Fluoride Varnish - 00856596006403

A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Dental Alliance Holdings LLC
Mint
Not in Commercial Distribution

  • 00856596006403 ()


  • Dental cavity varnish

CariFree Fluoride Varnish - 00856596006373

A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Dental Alliance Holdings LLC
CTX2
Not in Commercial Distribution

  • 00856596006373 ()
Raspberry

  • Dental cavity varnish
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