SPMG_S

Organization name

FertiPro

SRN

BE-MF-000000313

Manufacturer status

Active

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

• CW008

  SpermMar Test IgG Latex particles contain 0.1% bovine serum albumin of US origin; SpermMar Test IgG latex particles are coated with human IgG; SpermMar Test IgG Antiserum does contain rabbit antiserum to human IgG
• CW011

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

Primary placement in Belgium; available across 32 countries total.

Trade name

not provided

UDI-DI code

05411967000036

Basic UDI-DI

5411967SPMGS135

Reference / catalog number

SPMG_S

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 is a semi-quantitiative, non-automated, diagnostic kit for detecting antisperm antibodies of the IgG class on spermatozoa in human semen or serum. The single kit contains 2 reagents (antiserum and latex particles).

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• W0102109013SPERM ANTIBODIES

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