FDA UDI
In Commercial Distribution
🇺🇸 United States
Indole Reagent - p-Dimethylaminocinnamaldehyde
DI: 00810048900510
·
Model: AS-701
·
ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Indole Reagent - p-Dimethylaminocinnamaldehyde
- Primary DI
- 00810048900510
- Version / Model
- AS-701
- Catalog Number
- AS-701
- Company Name
- ANAEROBE SYSTEMS
- Labeler DUNS
- 021192653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-01
- Public Version
- 1
- Public Version Date
- 2020-05-11
- Public Version Status
- New
- Public Device Record Key
- 4d573126-8621-44d9-aa81-e5fde6855035
Device Description
AS-701 Indole reagent is intended for use in the Spot-Indole Test for detection of indole production by anaerobic bacteria. p-Dimethylaminocinnamaldehyde. 30 mL fill volume. 30 mL dropping bottle. 1 bottle per pack.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43714 | Tryptophan utilization/spot indole microbial reagent IVD | A reactant intended to be used in microbial testing to detect tryptophan metabolites (e.g., indole, indole-pyruvic acid) produced via enzymatic breakdown by a microorganism isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810048900510 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius