← Back to catalogue

Antisera to Human Immunoglobulins Pentavalent (G +4 more)

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E) FDA UDI
Generic Name
Polyvalent human immunoglobulin antibody IVD, reagent FDA UDI
Model / Reference
9251 FDA UDI

Identifiers

Primary DI / UDI-DI
M52592510 FDA UDI
FDA Product Code
CFF FDA UDI
GMDN Term
Polyvalent human immunoglobulin antibody IVD, reagent FDA UDI
Models / Variants
G FDA UDI
A FDA UDI
M FDA UDI
D FDA UDI
E FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

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: Polyvalent human immunoglobulin antibody IVD, reagent

Antisera to Human Immunoglobulins Pentavalent (G +4 more) by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — 5 models

Similar devices

Also classified as Polyvalent human immunoglobulin antibody IVD, reagent.

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
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI 669585b8-2332-4566-b154-930ba8b7f165 33 fields · synced Jun 9, 2026