102600

Organization name

Reagena Oy

SRN

FI-MF-000002804

Manufacturer status

Active

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

• CW106

  EUDAMED did not publish a description for this code.
• CW095

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW058

  EUDAMED did not publish a description for this code.
• CW137

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW313

  EUDAMED did not publish a description for this code.
• CW139

  EUDAMED did not publish a description for this code.
• CW057

  EUDAMED did not publish a description for this code.
• CW091

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW117

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 32 countries total.

Trade name

not provided

UDI-DI code

06430074452421

Basic UDI-DI

6430074451026009T

Reference / catalog number

102600

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Grams Staining Kit is intended to be used in Gram staining of bacteria. The device is intended for in vitro diagnostic use by trained laboratory personnel. The kit contains Crystal violet 2 % m/V, Lugol solution, Safranin solution and Acetone spirit 1+1.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0104010804STAINS

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

Certificate health across this manufacturer's portfolio.