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QwikCheck Test Strips

FDA UDI

Class II (US FDA UDI)

by M.e.s. Medical Electronic Systems Ltd.

Identity

Trade Name
QwikCheck Test Strips FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Model / Reference
0700 FDA UDI

Identifiers

Catalog Number
0700 FDA UDI
Primary DI / UDI-DI
07290012140167 FDA UDI
510(k) Number
K063864 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 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

Yes

FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

QwikCheck Test Strips by M.e.s. Medical Electronic Systems Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.e.s. Medical Electronic Systems Ltd.

Sources (1)

  • FDA UDI 1a5b9f34-1877-4cf3-bcd3-6ec2c506d26b 34 fields · synced May 30, 2026