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EXPLORO Highly Sensitive NICOTINE URINE TEST

FDA UDI

Class I (US FDA UDI)

by Safecare Biotech (Hangzhou) Co., Ltd.

Identity

Trade Name
EXPLORO Highly Sensitive NICOTINE URINE TEST FDA UDI
Generic Name
Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical FDA UDI
Model / Reference
25 tests FDA UDI

Identifiers

Catalog Number
COT200NGML FDA UDI
Primary DI / UDI-DI
06974246461014 FDA UDI
FDA Product Code
MRS FDA UDI
GMDN Term
Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3220 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: Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical

EXPLORO Highly Sensitive NICOTINE URINE TEST by Safecare Biotech (Hangzhou) Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Safecare Biotech (Hangzhou) Co., Ltd.

Sources (1)

  • FDA UDI 40908e5c-d39f-43af-8eda-dc8c43d2e60a 33 fields · synced Jun 6, 2026