LeukoGnost NSE, for at least 100 tests

Organization name

BioGnost Ltd.

SRN

HR-MF-000022153

Manufacturer status

Active

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

• CW133

  EUDAMED did not publish a description for this code.
• CW038

  EUDAMED did not publish a description for this code.
• CW043

  EUDAMED did not publish a description for this code.
• CW044

  EUDAMED did not publish a description for this code.

Primary placement in Croatia; available across 32 countries total.

Trade name

LeukoGnost NSE, for at least 100 tests

UDI-DI code

03858892122464

Basic UDI-DI

385889212HPC30702CYTOS9

Reference / catalog number

LKG-NSE

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

Diagnosis of hematological diseases and leukemia classification contains: Reagent 1 (Sodium nitrite, solution) Reagent 2 (Pararosaniline, solution) Reagent 3 (NSE buffer) Reagent 4 (NSE substrate) Reagent 5 (NSE inhibitor)

Additional information URL

https://www.biognost.com/

Clinical sizes

No clinical sizes registered for this device.

• W01030702CYTOCHEMICAL STAINING REAGENTS

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