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FDA Approved Manufacturing Procedures Available for Purchase

IBI offers many  FDA 510(k) approved bio-analytical formulations. Using these formulations, your organization will save time developing, analyzing and preparing formulations for FDA approval. For IBI pre-approved formulations or other data please fill out and submit the mail form and IBI will have a technician review your options and costs. Also included are manufacturing  procedures, filling procedures  and instrument protocols. All manuals in hard cover, diskette and CD Rom are available. A high-speed thermal printer for box and bottle labels.

 

 

 

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  (uranyl magnesium acetate)

*

Uranyl Magnesium 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

 

 

  

 

AVAILABLE CHEMISTRY ANALYZER APPLICATIONS & SETTINGS

  Part # Abbott Spectrum Abbott VP Abbott Alcyon ASCA/AGII ATAC 6000 ATAC 8000 Bayer Opera Beckman 700

Beckman CX

 Chemwell

Cobas Bio-Farza

Cobas Mira

 Dimension

Express 550

Manual Analyzers
Acid Phos  365 X X   X X X X X X   X X   X X
Albumin 271 X X X X X X X X X X X X X X X
Alk Phos 217 X X X X X X X X X X X X X X X
ALT 269 X X X X X X X X X X X X X X X
Amylase 351 X X X X X X X   X X X X X X X
Apolipoprotein A-1 640 NEW                            
Apolipoprotein B 645 NEW                            
AST 239 X X X X X X X   X X X X X X X
b-Hydroybutyrate 670 NEW                            
Direst Bilirubin 196 X X   X X X X X X X X X   X X
Total Bilirubin 192 X X   X X X X   X X X X   X X
BUN 148 X X X X X X X X X X X X X X X
Calcium 112 X X X X X X X X X X X X   X X
CO2 340 472   X X X X   X X X   X X   X X
Chloride 291 X X   X X   X   X   X X   X X
Cholesterol 152 X X X X X X X X X X X X X X X
CK 248 X X X X X X X X X X X X X X X
CK-MB 250 NEW                            
Creatinine 256 X X X X X X X X X X X X X X X
CRP-HS 650 NEW                            
Fructosamine 630 NEW                            
GGT 302 X X X X X X X X X X X X   X X
Glucose HK 136 X X X X X X X X X X X X X X X
Glucose Oxidase   NEW     X                     X
HBDH   NEW                            
autoHDL 500 X   X   X X     X X X X X X X
HDL 158 X X X X X X   X X   X X X X X
Hemoglobin   NEW     X                   X X
Iron 202 & 203 X X   X X X X   X X X X   X X
LDH-L 228 X X X X X X X X X X X X   X X
autoLDL 218 X   X   X X     X     X X X X
Lipase 181 X X X X X       X   X X X X X
Magnesium 392 X X X X X X     X X X X X X X
Micro Albumin 600 NEW                            
MicroProtein 205 X X   X         X     X   X X
Phosphorus 128 X X X X X X X X X X X X   X X
Total Protein 171 X X X X X X X X X X X X X X X
Triglyceride 452 X X X X X X X X X X X X   X X
Uric Acid 169 X X X X X X X X X X X X X X X

Specifications subject to change with no notice!

 

 

 
 
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