Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Biohazard During maintenance work, make sure to wear Latex gloves and overalls to prevent infection, and wear protective glasses when necessary. Do not throw away lint-free cloth for wiping at will. Please dispose of it properly in accordance with relevant regulations.
• CW999

  Warning Do not carry out maintenance work not explicitly stated in this chapter. Otherwise, it may cause system damage and personal injury. Do not touch components other than those that are clearly stated to be operated and maintained by users themselves. If the system is repaired without authorization, it may lead to system damage and personal injury, and make the terms promised in the maintenance contract no longer valid. After the maintenance work is completed, please confirm that the system works normally. Do not spill water, reagents, and other liquids on the mechanical or electrical parts of the system to prevent the water from entering the analyzer and thus damage it. If the analyzer is not going to be used in a long time (more than 1 weeks), or it needs to be carried, have it maintained by our customer service department or the local distributor to make sure it can still work normally in the next use. Do not perform maintenance during active testing or while the analyzer is running, as this may lead to inaccurate results, system damage, serious personal injury. For all operations that require the analyzer to be powered off, take care to disconnect it from the power supply to avoid personal injury. Keep the work area clean during inspection and maintenance.

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ i2000

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08800111720260

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

88001117IPAA01IA02V8

Reference / catalog number

16IA200

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

STANDARDTM i2000 is an in vitro diagnostic device that is intended for qualitative or quantitative testing of analytes in human serum, whole blood, urine and cerebrospinal fluid samples, including vitamins detection, amino acids and blood drug concentration detection, hormones detection, myocardial disease detection, infectious disease detection, auto-antibody detection, tumor-related antigens detection, proteins and polypeptides detection, kidney disease and liver disease detection, and immune function detection. The STANDARD™ i2000 Analyzer consists of two units: control unit, analytical unit. ULTRA i2000 is an in vitro diagnostic device that is intended for qualitative or quantitative testing of analytes in human serum, whole blood, urine and cerebrospinal fluid samples, including vitamins detection, amino acids and blood drug concentration detection, hormones detection, myocardial disease detection, infectious disease detection, auto-antibody detection, tumor-related antigens detection, proteins and polypeptides detection, kidney disease and liver disease detection, and immune function detection. The ULTRA i2000 Analyzer consists of two units: control unit, analytical unit.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0201020102AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

• IVDR Class A medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.