Identity
- Trade Name
- PRAS Liquid Dental Transport Medium (LDT) FDA UDI
- Generic Name
- Anaerobic transport medium IVD FDA UDI
- Device Name
- AS-916 Liquid Dental Transport Medium (LDT) is a buffered mineral salt based liquid medium with reducing agents designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 1 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-916 FDA UDI
- Description
- AS-916 Liquid Dental Transport Medium (LDT) is a buffered mineral salt based liquid medium with reducing agents designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 1 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-916 FDA UDI
- Primary DI / UDI-DI
- 00810048901289 FDA UDI
- FDA Product Code
- JSL FDA UDI
- GMDN Term
- Anaerobic transport medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 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: Anaerobic transport medium IVD
PRAS Liquid Dental Transport Medium (LDT) by Anaerobe Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaerobic transport medium IVD.
- AnaeroGRO — HARDY DIAGNOSTICS · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anaerobe Systems
Sources (1)
- FDA UDI e1b6375d-64dc-41f4-8af6-07169bb11888 36 fields · synced Jun 9, 2026