LeukoGnost SPENSE, for at least 50 tests

Organization name

BioGnost Ltd.

SRN

HR-MF-000022153

Manufacturer status

Active

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• CW010

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• CW133

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• CW038

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• CW043

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• CW044

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Primary placement in Croatia; available across 32 countries total.

Trade name

LeukoGnost SPENSE, for at least 50 tests

UDI-DI code

03858892123409

Basic UDI-DI

385889212HPC30702CYTOS9

Reference / catalog number

LKG-SPENSE

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 (Fast Blue RR/Fast Garnet GBC, solution) Reagent 3 (SPE buffer) Reagent 4 (SPE substrate) Reagent 5 (Fast Garnet GBC, solution) Reagent 6 (NSE buffer) Reagent 7 (NSE substrate) Reagent 8 (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