SpermMar Test IgG Positive Control

Organization name

FertiPro

SRN

BE-MF-000000313

Manufacturer status

Active

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

• CW011

  All human, organic material should be considered potentially infectious. Handle all specimens as if capable of transmitting HIV or hepatitis.
• CW008

  The SpermMar Test IgG Positive and Negative Controls contain human serum

Primary placement in Belgium; available across 32 countries total.

Trade name

SpermMar Test IgG Positive Control

UDI-DI code

05411967001378

Basic UDI-DI

5411967SPMGP12U

Reference / catalog number

SPMG_P

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The SpermMar Test IgG Positive and Negative Controls are control sera for use with the SpermMar Test IgG to verify the performance of the device

Additional information URL

https://fertipro.com/2019/11/04/spermmar-igg/

Clinical sizes

No clinical sizes registered for this device.

• W0102152011CONTROLS FOR AUTOIMMUNITY

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