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Control Cells

FDA UDI

Class II (US FDA UDI)

by American National Red Cross

Identity

Trade Name
Control Cells FDA UDI
Generic Name
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI
Device Name
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT). FDA UDI
Model / Reference
510400/510402 FDA UDI
Description
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT). FDA UDI

Identifiers

Primary DI / UDI-DI
00858400005091 FDA UDI
FDA Product Code
KSF FDA UDI
GMDN Term
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9650 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

Yes

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Immunoglobulin-sensitized reagent red blood cell IVD, control

Control Cells by American National Red Cross — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunoglobulin-sensitized reagent red blood cell IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American National Red Cross

Sources (1)

  • FDA UDI 4606e578-29d6-4c56-8e44-99307c84b0c1 35 fields · synced Jun 1, 2026