|
Method |
510(k) # |
Methodological
Principle |
|
|
|
|
|
ACID PHOSPHOTASE |
* |
a-napthyl phosphate, colorimetric |
|
ALANINE
AMINOTRANSFERASE (ALT)(GPT) |
K822494 |
DNPH, colorimetric |
|
ALBUMIN (BCG) |
K832747 |
BCG colorimetric |
|
ALKALINE
PHOSPHOTASE (kinetic, nitro-p-phos) |
K861638 |
p-nitro phenyl phosphate, kinetic |
|
AMYLASE (enzymatic
a
amylse) |
K860245 |
Caraway, Starch-Iodide |
|
BILIRUBIN, TOTAL &
DIRECT (Diazo colorimetric) |
* |
Diazo Colorimetric |
|
BUN BERTHELOT (indophenol) |
K831414 |
Urease - Berthelot, colorimetric |
|
CALCIUM (cresophthalein
complexone) |
* |
Cresophthalein complexone |
|
CHLORIDE DIRECT
(mercuric thiocyanate) |
* |
Mercuric Thiocyanate |
|
CHOLESTEROL,
enzymatic (esterase/oxidase) |
k811760 |
Enzymatic. colorimetric |
|
CK-CPK (UV
differential rate kinetic) |
K823211 |
NAC activated, HK/G-6-PDH/NADH, UV |
|
CREATININE DIRECT (alk
picrate kinetic) |
* |
Jaffee, Alkaline Picrate, kinetic |
|
CREATININE PICRATE
(alk picrate) |
* |
Direct, alk picrate + acid, differential |
|
GGT |
K770992 |
Szasz, GPNA substrate |
|
GLUCOSE (UV) |
K851514 |
Hexokinase / G6PDH, UV |
|
GLUCOSE (enzyme
color reagent) |
K813555 |
Glucose Oxidase / Trinder |
|
IRON & Iron
Binding (ferrozine) |
K810085 |
Ferrozine |
|
IRON & Iron
Binding (bathophenanthroline) |
K810086 |
Bathophenantroline |
|
LDH-L (enzymatic,
kinetic, liquid) |
K810083 |
L -> P, NAD/NADH |
|
LDH, colorimetric |
K820768 |
Diaphorase / INT |
|
PHOSPHORUS (phosphomolybdate) |
* |
Phosphomolybdate |
|
POTASSIUM
(colorimetric, turbidimetric) |
* |
Tetraphenyl boron, colorimetric |
|
PROTEIN TOTAL
BIURET |
* |
Biuret |
|
SGOT-AST (UV) |
K822493 |
UV, NAD/NADH |
|
SODIUM (urinyl
acetate) |
* |
Urinyl Acetate, colorimetric |
|
TRIGLYCERIDES (lipase,glycerol
kinase) |
K802256 |
Enzymatic. colorimetric |
|
URIC ACID
COLORIMETRIC, URICASE |
K820632 |
Uricase, DCHBS, colorimetric |
|
URIC ACID TPTZ (phosphotugstate) |
K810088 |
Phosphotungstic acid |
|
*
Method in commercial distribution before the 1976 ammendment |
|