Identity
- Trade Name
- Spot Indole Reagent (10ml) FDA UDI
- Generic Name
- Tryptophan utilization/spot indole microbial reagent IVD FDA UDI
- Device Name
- The active ingredient in our Spot Indole Reagent is p-dimethylaminocinnamaldehyde (PACA). The reagent will turn blue in the presence of Indole produced during Tryptophan degradation. FDA UDI
- Model / Reference
- PL.391-10 FDA UDI
- Description
- The active ingredient in our Spot Indole Reagent is p-dimethylaminocinnamaldehyde (PACA). The reagent will turn blue in the presence of Indole produced during Tryptophan degradation. FDA UDI
Identifiers
- Catalog Number
- PL.391-10 FDA UDI
- Primary DI / UDI-DI
- 05060472466785 FDA UDI
- FDA Product Code
- JSF FDA UDI
- GMDN Term
- Tryptophan utilization/spot indole microbial reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2320 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: Tryptophan utilization/spot indole microbial reagent IVD
Spot Indole Reagent (10ml) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tryptophan utilization/spot indole microbial reagent IVD.
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- Indole Reagent - p-Dimethylaminocinnamaldehyde — Anaerobe Systems · Class I
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 de2669cc-ad64-4a63-b76a-885ae4e0f73b 34 fields · synced May 30, 2026