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pHix

FDA UDI

Class I (US FDA UDI)

by Immucor, Inc.

Identity

Trade Name
pHix FDA UDI
Generic Name
pH-adjusted buffer solution IVD FDA UDI
Device Name
This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box. FDA UDI
Model / Reference
0005070 FDA UDI
Description
This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box. FDA UDI

Identifiers

Catalog Number
0005070 FDA UDI
Primary DI / UDI-DI
10888234000501 FDA UDI
FDA Product Code
JCC FDA UDI
GMDN Term
pH-adjusted buffer solution IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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

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: pH-adjusted buffer solution IVD

pHix by Immucor, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as pH-adjusted buffer solution IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI 41afcc7b-b00f-4efb-a9d2-aca7a4b97400 36 fields · synced May 30, 2026