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{
"ProductData": {
"RelatedLinks": "",
"RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.",
"RegulatoryDisclaimer2": "",
"StainLocalization": [
""
],
"DisclaimerGroup2": null,
"ProductNameGlobal": "NH3 Bio",
"DisclaimerGroup1": "",
"ControlTissue": [
""
],
"BrandName": "NH3 Bio",
"LicenseDisclaimers": [
],
"Isotypes": "",
"RegulatoryDisclaimer3": "",
"ID": "3.8.10.2.4.3",
"ProductNameAddition": "Test kit for the Cedex Bio Analyzer",
"Species": [
""
],
"Clone": ""
},
"ProductSpec": {
"ProductSpecVariant": {
"Chapters": [
{
"Language": "English",
"Value": "Keep at +2 to +10°C for on-board use. After first use on the instrument, the reagents are stable for up to 4 weeks. ",
"Name": "Storage Conditions (Working Solution)"
},
{
"Language": "English",
"Value": "Store the reagent at +2 to +8°C.",
"Name": "Storage Conditions (Product)"
},
{
"Language": "English",
"Value": "Kit for determination of ammonia.",
"Name": "Product Description"
},
{
"Language": "English",
"Value": "Unit of measure is \"piece\".",
"Name": "CB - Order Information"
},
{
"Language": "English",
"Value": "Method: Enzymatic photometric assay using glutamate dehydrogenase. Recovery: ±10%",
"Name": "CB - Specification"
},
{
"Language": "English",
"Value": "Solved ammonia (ammonium ions, NH4+) in the presence of glutamate dehydrogenase (GLDH) reacts with 2-oxoglutarate and NADPH in a reductive amination to form L-glutamate and NADP+. The decrease of NADPH is directly proportional to the ammonia concentration and is measured photometrically at 340 nm.
",
"Name": "Principle"
},
{
"Language": "English",
"Value": "Cedex Bio test definition:
Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction direction Decrease
Wavelength A/B 340/629 nm
Calc. first/last 7/31
Unit mmol/L
Reaction mode R1-R2-S
Pipetting parameters:
R1 40 μl + 30 μl Diluent (H2O)
R2 20 μl + 30 μl Diluent (H2O)
Sample 2 μl + 10 μl Diluent (H2O)
Total volume 132 μl
Calibration:
Calibrator Calibrator B Bio (CAL B, 541)
Calibration mode Linear regression
Calibration intervall Each new lot, and if recalibration is required due to QC results
Quality control:
Control B Level 1 Bio (CONB1, 401)
Control B Level 2 Bio (CONB2, 402)
Control B Level 3 Bio (CONB3, 403)
Use the recommended control material. Other suitable control material can be used in addition.
For quality control in the low range of test protocol NH3LB, prepare an appropriate control by diluting \"Control B Level 1 Bio\" 1:5 using water as the diluent. Divide the NH3 concentration and the \"1s\" value of the original control by 5 for entering the lot-specific NH3 values.
Control intervals and acceptance limits should be adapted to each laboratory's individual requirements. If values do not fall within the defined limits, corrective measures and recalibration are required",
"Name": "Protocols - Help Corner"
},
{
"Language": "English",
"Value": "NH3 concentration can be determined in following ranges:
NH3LB: 0.0278 - 1.389 mmol/L (0.473 - 23.66 mg/L)
NH3B: 0.278 - 13.89 mmol/L (4.73 - 236 mg/L)
NH3D: 5.56 - 278 mmol/L (95 - 4720 mg/L), up to 5.56 mol/L (95 g/L) with postdilution
Conversion Factors Conversion factors for analyte concentration:
1 mmol/L NH3 = 17.03 mg/L NH3
1 mg/L NH3 = 58.72 μmol/L NH3
1 mmol/L NH4+ = 18.04 mg/L NH4+
1 mg/L NH4+ = 55.43 μmol/L NH4+
Traceability This method has been standardized against a standard reference material (SRM 194).
Precision Representative performance data on Cedex Bio analyzers are shown. Results obtained in individual laboratories may differ. Precision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 30 days).
Level 1
Level 2
Level 3
Mean
0.70 mmol/L (11.9 mg/L)
2.34 mmol/L (40.0 mg/L)
2.96 mmol/L (50.4 mg/L)
CV in-run
3.0%
2.9%
1.4%
CV inter-run
5.9%
3.4%
1.3%
",
"Name": "Background Information - Help Corner"
},
{
"Language": "English",
"Value": "
Analyzer and accessories
Cedex Bio Analyzer*, including accessories and disposables
For measurement of acute pancreatitis (pancreatic α-amylase) in human serum and urine selective blocking of salivary α-amylase isoenzyme is achieved in the presence of the pancreatic h-α-amylase.Qualified for thecobas platforms.
Product Description
For measurement of acute pancreatitis (pancreatic α-amylase) in human serum and urine selective blocking of salivary α-amylase isoenzyme is achieved in the presence of the pancreatic h-α-amylase.Qualified for thecobas platforms.
Ordering
Name
PackSizePIM360
Description
11543601103
custom fill
MAKM-Tu66C7-IgG(BR)SQ
Notes
Will be supplied as "MAK<H-S-Amy>M-Tu66C7-IgG(BR)SQ". Unit of measure is "g active ingredient".
