← Back to catalogue

T Testahead URINARY TRACT INFECTION TEST

FDA UDI

Class I (US FDA UDI)

by Safecare Biotech (Hangzhou) Co., Ltd.

Identity

Trade Name
T Testahead URINARY TRACT INFECTION TEST FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Model / Reference
12 tests FDA UDI

Identifiers

Catalog Number
UTI-1021 FDA UDI
Primary DI / UDI-DI
06974246462370 FDA UDI
FDA Product Code
LJX FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.7675 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

No

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 urine analyte IVD, kit, rapid colorimetric, clinical

T Testahead URINARY TRACT INFECTION TEST by Safecare Biotech (Hangzhou) Co., Ltd. — Class I — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Safecare Biotech (Hangzhou) Co., Ltd.

Sources (1)

  • FDA UDI e93935d9-0726-47d2-b9fc-2cf75a59b139 33 fields · synced Jun 8, 2026