Stromatolyser-NR

FDA UDI

Class I (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name: Stromatolyser-NR FDA UDI
Generic Name: Blood cell lysis reagent IVD FDA UDI
Device Name: Nucleated red blood cell test kit for hematology analyzer Contains Stromatolyser-NR Lysing Reagent (SNR-200) and Stromatolyser-NR Dye (SNR-800) FDA UDI
Model / Reference: SNR-700A FDA UDI
Description: Nucleated red blood cell test kit for hematology analyzer Contains Stromatolyser-NR Lysing Reagent (SNR-200) and Stromatolyser-NR Dye (SNR-800) FDA UDI

Identifiers

Primary DI / UDI-DI: 00664369201395 FDA UDI
FDA Product Code: GGK FDA UDI
GMDN Term: Blood cell lysis reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1000 Milliliter FDA UDI
Total Volume — 12 Milliliter FDA UDI

Category: Blood cell lysis reagent IVD

Stromatolyser-NR by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sysmex Corp.

Sources (1)

FDA UDI 3b70cd86-d8bd-4117-b20e-5147ec56a349 36 fields · synced Jun 1, 2026