Identity
- Trade Name
- PRAS Dilution Blanks FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- AS-9183 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250 mL Pyrex bottle. Transparent colorless liquid. 1 bottle per pack. FDA UDI
- Model / Reference
- AS-9183 FDA UDI
- Description
- AS-9183 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250 mL Pyrex bottle. Transparent colorless liquid. 1 bottle per pack. FDA UDI
Identifiers
- Catalog Number
- AS-9183 FDA UDI
- Primary DI / UDI-DI
- 00810048901227 FDA UDI
- FDA Product Code
- JSC FDA UDI
- GMDN Term
- Buffered sample diluent IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2350 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: Buffered sample diluent IVD, manual
PRAS Dilution Blanks by Anaerobe Systems — 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
- Anaerobe Systems
Sources (1)
- FDA UDI e347d083-7224-4b03-b270-a6463b4f91ac 36 fields · synced Jun 9, 2026