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SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000) FDA UDI
- Generic Name
- Test tube heater FDA UDI
- Model / Reference
- DAM-101-a-Sgl FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810124272999 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- GMDN Term
- Test tube heater FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 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
Yes
FDA UDI
Category: Test tube heater
SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000) by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID
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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 aaafae10-4909-45f2-b4b8-e7492d3ab538 32 fields · synced Jun 9, 2026