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Peg

FDA UDI

Class II (US FDA UDI)

by American National Red Cross

Identity

Trade Name
PEG FDA UDI
Generic Name
Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI
Device Name
PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution. FDA UDI
Model / Reference
510179 FDA UDI
Description
PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution. FDA UDI

Identifiers

Primary DI / UDI-DI
00858400005107 FDA UDI
FDA Product Code
KSG FDA UDI
GMDN Term
Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9600 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

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: Polyethylene glycol (PEG) immunohaematology reagent IVD

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

Similar devices

Also classified as Polyethylene glycol (PEG) immunohaematology reagent IVD.

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 eff243f5-85a0-4c0f-bb3c-6990be8d4932 34 fields · synced May 30, 2026