Consumables

The characteristics of the “UREA UV LR” product are as follows:

Product Name: UREA UV LR

Analytical Method: Kinetic UV Method Urease-GLDH

Reference (REF): 10239

Batch Number (LOT): 6042

Contents (Cont.): 5 x 50 ml (indicating 5 vials of 50 ml each)

Manufacturer: SGM Italia srl

Manufacturer’s Address: Via Olivadi 20 – 00126 Rome – Italy

Certification: CE Mark for In Vitro Diagnostic Medical Devices (IVD CE)

The characteristics of the Amylase LR assay kit are as follows:

Product Name: Amylase LR.

Use: Kit for the determination of amylase in serum, plasma, and urine.

Method: CNPG3 kinetic method.

Reference (REF): 10206.

Contents: 5 x 12 ml (R1 5 x 12 ml).

Lot Number (LOT): 5836.

Device Type: IVD (In Vitro Diagnostic).

Storage Conditions: Between 2°C and 8°C.

Warnings:
H412: Harmful to aquatic life with long-lasting effects.
EUH032: Contact with acids liberates very toxic gas.
Certification: CE Marking.
Manufacturer: SGM Italia – Via Olivadi 20 – 00126 Rome – Italy

The characteristics of the GOT-AST LR diagnostic kit are as follows:

Product Name: GOT-AST LR (Glutamate Oxaloacetate Transaminase – Aspartate Aminotransferase, Long Range).

Method: Timed kinetic method according to the recommendations of the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).

Use: In vitro diagnostic (IVD) medical device for the quantitative determination of AST/GOT activity in human serum or plasma, primarily for the screening and diagnosis of liver disorders.

Storage and Stability:
Recommended storage temperature: 2-8°C.
Stability of unopened reagents: Until the expiration date if stored between 2 and 8°C.
Stability after opening: The contents, placed in the analyzer at approximately 10°C, are stable for 28 days.

Kit composition:
Total contents: 5 x 50 ml.
Reagent R1: 5 x 40 ml (probably Buffer/Enzyme).
Reagent R2: 1 x 50 ml (α-oxoglutarate/Coenzyme).
Manufacturer: SGM.

Identification numbers:
Reference (REF): 10139.
Batch number (LOT): 5952.
Certification: CE marking, indicating compliance with European Union health, safety, and environmental protection requirements.

The characteristics of “URIC ACID LR” uric acid can be detailed as follows:

Product Name: URIC ACID LR (Long Range), used for the determination of uric acid.

Method: Colorimetric enzymatic method (Uricase-POD-PAP).

Reference (REF): 10158.

Batch Number (LOT): 5953B.

Contents (Cont): 4 x 40 + 4 x 10 ml.

Manufacturer: SGM, and address: “SGM Italia srl ​​- Via Olona 20 – 20036 Rescaldina – Italy”).

Certifications: CE and IVD (In Vitro Diagnostic) marking.

The characteristics of the lipase kit are as follows:

Product Name: LIPASE

Use: Kit for measuring lipase in serum or plasma.

Determination Method: Colorimetric determination.

Reference (REF): 10285.

Batch Number (LOT): 5874B.

Contents (Cont.): 2 x 20 + 1 x 10 + 1 x 5.

R1: 2 x 20 ml.

R2: 1 x 10 ml.

R3: 1 x 5 ml.

Manufacturer/Distributor: SGM Italia srl ​​- Via Olivadi 20 – 00126 Rome – Italy

The characteristics of the “TRIGLYCERIDES LR MONO” kit are as follows:
Product Name: TRIGLYCERIDES LR MONO
Use: Kit for measuring triglycerides in serum or plasma.
Method: Enzymatic colorimetric GPO-PAP method.
Reference (REF): 10165
Batch (LOT): 5905
Contents: 2 x 100 ml (R1 2 x 100 ml, R3 1 x 8 ml)
Manufacturer and Address: SGM Italia srl ​​- Via Olivadi 20 – 00126 Rome – Italy

The characteristics of the SGM Italia “CHOLESTEROL LR MONO Enzymatic Trinder method” total cholesterol enzymatic assay kit, based on similar information for cholesterol enzymatic assay kits, are as follows:

Assay method: Trinder enzymatic method (CHOD-POD, Phenol), using colorimetric spectrophotometry.

Reaction type: Endpoint.

Reading time: Approximately 5 minutes.

Kit composition: A single reagent and a standard for calibration. The kit contains 4 x 100 mL of reagent (R1) and 1 x 5 mL of standard.

Use: For in vitro diagnostic use only, reserved for professional laboratory use.

Stability/Storage: The serum is stable for several days between +2 and +8°C.

Precautions: Do not pipette by mouth; Follow precautions for handling laboratory reagents.

Sensitivity: The detection limit is approximately 1 mg/dL.

Interferences: Characteristics may vary depending on the analyzer used; interference with hemoglobin or bilirubin may be observed at certain concentrations.

The GAMMA GT LR diagnostic kit is a kit for measuring gamma-GT in serum or plasma using the SZASZ method.

Main characteristics:

Product type: In vitro diagnostic (IVD) medical device.

Enzyme measured: Gamma-glutamyl transferase (Gamma-GT or GGT).

Method: SZASZ method.

Sample: Serum or plasma.

Product reference (REF): 10228.

Batch number (LOT): 5835D.

Contents: The kit includes two reagents: R1 (5 x 40 ml) and R2 (1 x 50 ml).

Storage conditions: Between 2°C and 8°C.

Manufacturer: SGM Italia srl, based in Rome, Italy.

Certification: CE marked.

Intended Use: For the diagnosis and monitoring of hepatobiliary diseases by healthcare professionals in the laboratory.

The CK NAC LR kit features are as follows:

Product Name: CK NAC LR.

Use: Kit for measuring creatine kinase (CK) in serum or plasma.

Method: Optimized kinetic method DGKC-IFCC.

Reference (REF): 10197.

Batch Number (LOT): 5908.

Contents: 60 + 15 ml, including R1 (1 x 60 ml) and R2 (1 x 15 ml).

Manufacturer/Distributor: SGM Italia srl, located in Via Olivadi 20 – 00126 Rome, Italy.

Clinical Significance: CK measurement is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive muscular dystrophy. N-acetylcysteine ​​(NAC) acts as a CK activator.

Use: For in vitro diagnostic use only.

The following are the characteristics of the ALBUMIN LR kit:

Product Name: ALBUMIN LR.

Use: Kit for the determination of albumin in serum or plasma.

Method: BCG (Bromocresol Green) colorimetric method.

Reference (REF): 1004054.

Contents:
R1: 1 x 250 ml.
STD (Standard): 1 x 8 ml.
Total Quantity (Cont.): 1 x 250 ml.
Batch Number (LOT): 5673B.
Use: IVD (In Vitro Diagnostic) – for in vitro diagnostic use.
Compliance: CE marked, indicating compliance with European standards.
Manufacturing: Made in Italy.
Manufacturer/Distributor: SGM Italia – Via Olivadi 20 – 00126 Rome – Italy.

The product “LDH LR Kinetic optimized method SCE” is a reagent for the determination of Lactate Dehydrogenase (LDH) with the following characteristics:

Method: Kinetic optimized method SCE. LDH catalyzes the reduction of pyruvate by NADH, and the rate of NADH reduction is measured photometrically, being proportional to the LDH concentration.

Reference (REF): 10118.

Batch number (LOT): 5965B.

Contents (Cont.): The kit contains 4 x 20 ml in total, consisting of:
R1: 4 x 16 ml.
R2: 1 x 16 ml.

Manufacturer: SGM Italia srl, located at Via Olivadi 20 – 00126 Rome – Italy.

Clinical significance: LDH is an enzyme present in the body, and elevated serum levels may indicate liver disease, myocardial infarction, kidney problems, muscular dystrophy, and anemia.

The following are the characteristics of the product “GLUCOSE LR MONO”:

Product Name: GLUCOSE LR MONO

Method: GOD-POD (Glucose Oxidase-Peroxidase) colorimetric enzymatic method

Use: IVD (In Vitro Diagnostics)

Certifications: CE Marked

Storage Conditions: Between 2°C and 8°C

Reference Number (REF): 10013

Batch Number (LOT): 5891

Contents: 4 x 100 ml (4 vials of 100 ml each)

Components: R1 4 x 100 ml (one reagent, also in 4 x 100 ml)

Manufacturer: SGM Italia srl ​​- Via Olivadi 20 – 00126 Rome – Italy