← Back to catalogue

Red Cell Storage Solution

FDA UDI

Class I (US FDA UDI)

by American National Red Cross

Identity

Trade Name
Red Cell Storage Solution FDA UDI
Generic Name
Cell preservation/storage/dilution solution IVD FDA UDI
Device Name
Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing. FDA UDI
Model / Reference
510265 FDA UDI
Description
Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing. FDA UDI

Identifiers

Primary DI / UDI-DI
00858400005114 FDA UDI
FDA Product Code
GIF FDA UDI
GMDN Term
Cell preservation/storage/dilution solution IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.8200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Cell preservation/storage/dilution solution IVD

Red Cell Storage Solution by American National Red Cross — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cell preservation/storage/dilution solution IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
American National Red Cross

Sources (1)

  • FDA UDI dea2fc78-e788-4d92-a9a9-913edb748aea 34 fields · synced May 31, 2026