Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Mycoplasma pneumoniae IgM EIA — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 10, 2024

Mycoplasma pneumoniae IgM EIA

B-06438172167018

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172167018
Reference / catalog number: 6111420

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW008
All human materials used in the preparation of the calibrators/controls in the kit have been tested for the presence of the antibodies to HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) as well as Hepatitis B surface antigen (HBsAg) and found to be non-reactive. Because no test method can offer complete assurance that HIV, hepatitis B virus, HCV, or other infectious agents are absent, these calibrators and controls as well as samples should be handled at the Biosafety level 2 as recommended for any potentially infectious human serum or blood sample in the Centers for Disease Control/National Institutes for Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 2007

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: Mycoplasma pneumoniae IgM EIA
UDI-DI code: 06438172167018
Basic UDI-DI: B-06438172167018
Reference / catalog number: 6111420
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Labsystems Diagnostics’ Mycoplasma pneumoniae IgM test is developed for the detection of IgM antibodies specific to Mycoplasma pneumoniae in human serum or plasma.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010802MYCOPLASMA ANTIBODY ASSAYS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Biocard Chlamydia pneumoniae IgMB-06416842034013On the market Biocard Helicobacter pylori IgGB-06416842818019On the market 3-035-000B-06416842035010On the market 3-028-200B-06416842928015On the market Biocard™ H pylori IgG HomeB-06416842918030On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.