FDA UDI
In Commercial Distribution
🇺🇸 United States
PRAS Tryptic Soy Agar with N-acetylmuramic acid (TSA-NAM)
DI: 00810048900343
·
Model: AS-6421
·
ANAEROBE SYSTEMS
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- PRAS Tryptic Soy Agar with N-acetylmuramic acid (TSA-NAM)
- Primary DI
- 00810048900343
- Version / Model
- AS-6421
- Catalog Number
- AS-6421
- Company Name
- ANAEROBE SYSTEMS
- Labeler DUNS
- 021192653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- 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
- 6680a97f-de69-45a2-accb-04222dfe210d
Device Description
AS-6421 Tryptic Soy Agar with N-acetylmuramic acid (TSA-NAM) is an enriched medium used for the isolation and presumptive identification of periodontal pathogens, including Tannerella forsythia. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KZI | Culture Media, Enriched | Microbiology | 866.2330 | 1 |
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58688 | Enriched agar culture medium IVD | An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810048901654 | GS1 | ||||
| Primary | 00810048900343 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius