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Specific Protein Control - Level 3 (sp Control 3)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3) FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, control FDA UDI
Model / Reference
PS10223 FDA UDI

Identifiers

Primary DI / UDI-DI
05055273215694 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

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 clinical chemistry protein IVD, control

Specific Protein Control - Level 3 (sp Control 3) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry protein 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 5a58b2ff-5764-479f-a410-1e2cb1d0e0c2 32 fields · synced May 31, 2026