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APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) FDA UDI
Generic Name
Multiple apolipoprotein IVD, control FDA UDI
Device Name
Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B. FDA UDI
Model / Reference
LV10357 FDA UDI
Description
Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B. FDA UDI

Identifiers

Catalog Number
LV10357 FDA UDI
Primary DI / UDI-DI
05055273216271 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple apolipoprotein 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Multiple apolipoprotein IVD, control

APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple apolipoprotein IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 79c0a6f0-1fb0-4058-8e73-eb9c0d4baf5f 36 fields · synced Jun 8, 2026