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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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AIMSCREEN BAR - 00695684421250

Lateral flow immunoassay for the detection of Barbiturates (BAR) in urine.
GERMAINE LABORATORIES, INC
42125
In Commercial Distribution

  • 00695684421250 ()
  • 00695684421251 ()


  • Barbiturate IVD, kit, rapid ICT, clinical

AIMSCREEN BUP - 00695684420253

Lateral flow immunoassay for the detection of Buprenorphine (BUP) in urine.
GERMAINE LABORATORIES, INC
42025
In Commercial Distribution

  • 00695684420253 ()
  • 00695684420251 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

AIMSCREEN AMP - 00695684411251

Lateral flow immunoassay for the detection of Amphetamine (AMP) in urine.
GERMAINE LABORATORIES, INC
41125
In Commercial Distribution

  • 00695684411251 ()
  • 00695684411252 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical

Glucose Standard (100 mg/dL) - 00657498001165

For the Quantitative Determination of Glucose in Serum, Plasma or CSF.
STANBIO LABORATORY, L.P.
1072-030
In Commercial Distribution

  • 00657498001165 ()
1072-030

  • Glucose IVD, reagent

Urea Nitrogen (BUN) Liqui-UV® - 00657498001080

For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum.
STANBIO LABORATORY, L.P.
2020-500
In Commercial Distribution

  • 00657498001080 ()
2020-500

  • Urea IVD, kit, enzyme spectrophotometry

Urea Nitrogen (BUN) Liqui-UV® - 00657498001073

For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum.
STANBIO LABORATORY, L.P.
2020-430
In Commercial Distribution

  • 00657498001073 ()
2020-430

  • Urea IVD, kit, enzyme spectrophotometry

Glucose LiquiColor® - 00657498000830

For the Quantitative Determination of Glucose in Serum, Plasma or CSF.
STANBIO LABORATORY, L.P.
1071-001
In Commercial Distribution

  • 00657498000830 ()
1071-001

  • Glucose IVD, kit, spectrophotometry

Glucose LiquiColor® - 00657498000823

For the Quantitative Determination of Glucose in Serum, Plasma or CSF.
STANBIO LABORATORY, L.P.
1070-500
In Commercial Distribution

  • 00657498000823 ()
1070-500

  • Glucose IVD, kit, spectrophotometry

Glucose LiquiColor® - 00657498000816

For the Quantitative Determination of Glucose in Serum, Plasma or CSF.
STANBIO LABORATORY, L.P.
1070-125
In Commercial Distribution

  • 00657498000816 ()
1070-125

  • Glucose IVD, kit, spectrophotometry

Creatinine LiquiColor® - 00657498000762

For the quantitative enzymatic determination of creatinine in serum and urine.
STANBIO LABORATORY, L.P.
0430-500
In Commercial Distribution

  • 00657498000762 ()
0430-500

  • Creatinine IVD, kit, enzyme spectrophotometry
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