Identity
- Trade Name
- Mucolyse (10x100 mg) FDA UDI
- Generic Name
- Sputum liquefaction/decontamination reagent IVD FDA UDI
- Device Name
- Mucolyse presents an effective sputum digestant supplied in a simple, convenient, economical and safe format. Each vial, containing lyophilised predetermined quantities of Dithiothreitol and Phosphate Buffer, reconstitutes with 10 ml of sterile water, and then dilutes to 100 ml of active digestant solution. FDA UDI
- Model / Reference
- PL.701 FDA UDI
- Description
- Mucolyse presents an effective sputum digestant supplied in a simple, convenient, economical and safe format. Each vial, containing lyophilised predetermined quantities of Dithiothreitol and Phosphate Buffer, reconstitutes with 10 ml of sterile water, and then dilutes to 100 ml of active digestant solution. FDA UDI
Identifiers
- Catalog Number
- PL.701 FDA UDI
- Primary DI / UDI-DI
- 20628429001008 FDA UDI
- FDA Product Code
- JSK FDA UDI
- GMDN Term
- Sputum liquefaction/decontamination reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2450 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
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: Sputum liquefaction/decontamination reagent IVD
Mucolyse (10x100 mg) by Pro-Lab, Incorporated — 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
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 274e35b1-c002-47d3-a2ab-79dbe5de8c03 34 fields · synced Jun 1, 2026