SpermMar Test IgA Complete kit

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

  SpermMar Test IgA contains 0.1% Bovine Serum Albumin of US origin; SpermMar Test IgA latex particles are coated with a monoclonal rat anti-human IgA.

Primary placement in Belgium; available across 32 countries total.

Trade name

SpermMar Test IgA Complete kit

UDI-DI code

05411967001347

Basic UDI-DI

5411967SPMAC1YL

Reference / catalog number

SPMA_C

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 IgA is a semi-quantitative, non-automated, diagnostic kit for detecting antisperm antibodies of the IgA class on spermatozoa in human semen. The complete kit contains the single kit and lab disposables (micro slides, cover glasses, microcapillary pipettes with rubber bulb).

Additional information URL

https://fertipro.com/2019/10/28/spermmar-iga/

Clinical sizes

No clinical sizes registered for this device.

• W0102109013SPERM ANTIBODIES

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