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Identify Health

FDA UDI

Class II (US FDA UDI)

by Medical Distribution Group Inc

Identity

Trade Name
Identify Health FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Identify Health, 12 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, TCA1000, THC50) Contents: Test Cups - 25, Package Insert - 1, Security Seals - 25, For In Vitro Diagnostics Use FDA UDI
Model / Reference
ID-H12-2 FDA UDI
Description
Identify Health, 12 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, TCA1000, THC50) Contents: Test Cups - 25, Package Insert - 1, Security Seals - 25, For In Vitro Diagnostics Use FDA UDI

Identifiers

Catalog Number
ID-H12-2 FDA UDI
Primary DI / UDI-DI
01085072100703 FDA UDI
FDA Product Code
LFG FDA UDI
LDJ FDA UDI
DIS FDA UDI
DKZ FDA UDI
DJG FDA UDI
JXM FDA UDI
DIO FDA UDI
DJR FDA UDI
DJC FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3910 FDA UDI
862.3870 FDA UDI
862.3150 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3170 FDA UDI
862.3250 FDA UDI
862.3620 FDA UDI
862.3610 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Identify Health by Medical Distribution Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Distribution Group Inc

Sources (1)

  • FDA UDI aaa7b2ea-86e4-450a-b413-c83c1dd120bb 36 fields · synced Jun 8, 2026