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Advanced Instruments RBC Reagent Filtration Kit

FDA UDI

Class II (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name
Advanced Instruments RBC Reagent Filtration Kit FDA UDI
Generic Name
Syringe filter, clinical FDA UDI
Device Name
The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria FDA UDI
Model / Reference
111014 FDA UDI
Description
The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria FDA UDI

Identifiers

Catalog Number
111014 FDA UDI
Primary DI / UDI-DI
00816068020535 FDA UDI
FDA Product Code
GKL FDA UDI
GMDN Term
Syringe filter, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Syringe filter, clinical

Advanced Instruments RBC Reagent Filtration Kit by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe filter, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Instruments, LLC

Sources (1)

  • FDA UDI 6eb0ece1-b817-49f2-8690-2aae35408699 36 fields · synced Jun 8, 2026