Identity
- Trade Name
- Therapak FDA UDI
- Generic Name
- Drug-testing specimen collection kit IVD FDA UDI
- Device Name
- Single 45mL Bulk Supply Kit (CS/100) FDA UDI
- Model / Reference
- ACSK40056 FDA UDI
- Description
- Single 45mL Bulk Supply Kit (CS/100) FDA UDI
Identifiers
- Catalog Number
- ACSK40056 FDA UDI
- Primary DI / UDI-DI
- 07312058462819 FDA UDI
- FDA Product Code
- MPQ FDA UDI
- GMDN Term
- Drug-testing specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3260 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Drug-testing specimen collection kit IVD
Therapak by Therapak LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Therapak LLC
Sources (1)
- FDA UDI 9ab2866e-1f94-417e-b5eb-7a59c38923ce 34 fields · synced Jun 6, 2026