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Abx Pentra Immuno I Control L/H

FDA UDI

Class I (US FDA UDI)

by Horiba Abx

Identity

Trade Name
ABX PENTRA IMMUNO I CONTROL L/H FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, control FDA UDI
Model / Reference
1220001621 FDA UDI

Identifiers

Primary DI / UDI-DI
03610230004876 FDA UDI
510(k) Number
K061138 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple clinical chemistry protein IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

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: Multiple clinical chemistry protein IVD, control

Abx Pentra Immuno I Control L/H by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry protein IVD, control.

Cleared under the same submission

K061138 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Horiba Abx

Sources (1)

  • FDA UDI f854ef76-94a5-402b-857f-d1a450898a82 33 fields · synced Jun 8, 2026