Identity
- Trade Name
- CERTUM One Step Multi-Line Drug Screen EZ Split FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+<MDMA500> FDA UDI
- Model / Reference
- DBO-1107-401-a FDA UDI
- Description
- (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+<MDMA500> FDA UDI
Identifiers
- Catalog Number
- 4566581326 FDA UDI
- Primary DI / UDI-DI
- 00810124273828 FDA UDI
- FDA Product Code
- DIO FDA UDIDKZ FDA UDILDJ FDA UDIDIS FDA UDIJXM FDA UDIDJC FDA UDIDJG FDA UDILCM FDA UDILFG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3100 FDA UDI862.3870 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3910 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
No
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 drugs of abuse IVD, kit, rapid ICT, clinical
CERTUM One Step Multi-Line Drug Screen EZ Split by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Alere San Diego, Inc.
Sources (1)
- FDA UDI c806b138-5ff0-4350-b980-593ce9f16840 34 fields · synced Jun 9, 2026