PTS Panels Metabolic ChemistryTest Strips (15-ct)

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name: PTS Panels Metabolic ChemistryTest Strips (15-ct) FDA UDI
Generic Name: Multiple clinical chemistry enzyme IVD, kit, spectrophotometry FDA UDI
Device Name: PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. FDA UDI
Model / Reference: 2400 FDA UDI
Description: PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. FDA UDI

Identifiers

Catalog Number: 2400 FDA UDI
Primary DI / UDI-DI: 00381932400015 FDA UDI
510(k) Number: K070017 FDA UDI
FDA Product Code: NGO FDA UDI
LBR FDA UDI
JGY FDA UDI
NBW FDA UDI
NAQ FDA UDI
CGA FDA UDI
GMDN Term: Multiple clinical chemistry enzyme IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1705 FDA UDI
862.1475 FDA UDI
862.1345 FDA UDI
862.1175 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

PTS Panels Metabolic ChemistryTest Strips (15-ct) by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K070017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Polymer Technology Systems

Sources (1)

FDA UDI 86a7dadd-c2cc-4609-89c7-3c6bccfe5165 38 fields · synced May 30, 2026