Urease, Photometric, Urea Nitrogen
FDA product code CDN · 16 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1770
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-08-22 – 2019-03-14
CDN
2019-03-14
CDN
2013-10-28
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
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CDN
2013-05-21
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
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CDN
2012-08-10
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
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CDN
2011-09-08
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
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CDN
2000-07-20
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
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CDN
1997-07-24
CHOLESTECH BUN/CREATININE TEST SYSTEM
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CDN
1996-05-15
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
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CDN
1994-12-29
BUN QVET
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CDN
1992-10-13
KING DIAGNOSTICS UREA NITROGEN REAGENT
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CDN
1991-12-31
QUICKSTART UREA NITROGEN
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CDN
1982-08-05
UREA NITROGEN (ENZYMATIC) DETERMINATION
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CDN
1980-11-12
BUN REAGENT ASTRA 4 & 8 ANALYZERS
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CDN
1979-12-18
STATTEK BUN
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CDN
1978-08-21
BUN (UREASE) REAGENT
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CDN
1977-08-22
MULTISTAT III UREA NITROGEN TEST
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