SpermMar Test IgA Single kit

Organization name

FertiPro

SRN

BE-MF-000000313

Manufacturer status

Active

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

• 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.
• 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

SpermMar Test IgA Single kit

UDI-DI code

05411967002566

Basic UDI-DI

5411967SPMAS127

Reference / catalog number

SPMA_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 IgA is a semi-quantitative, non-automated, diagnostic kit for detecting antisperm antibodies of the IgA class on spermatozoa in human semen. The single kit contains 1 reagent.

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