Identity
- Trade Name
- InTray® TSA FDA UDI
- Generic Name
- Basic/simple nutrient agar culture medium IVD FDA UDI
- Device Name
- A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique. FDA UDI
- Model / Reference
- 1443 FDA UDI
- Description
- A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique. FDA UDI
Identifiers
- Catalog Number
- 21-443-001 FDA UDI
- Primary DI / UDI-DI
- B08814430 FDA UDI
- FDA Product Code
- JSG FDA UDI
- GMDN Term
- Basic/simple nutrient agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2300 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: Basic/simple nutrient agar culture medium IVD
InTray® TSA by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic/simple nutrient agar culture medium IVD.
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- OxyPRAS Plus Brucella Agar plate — Oxyrase, Inc. · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · 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
- Biomed Diagnostics, Inc.
Sources (1)
- FDA UDI 32b70c88-7938-4f90-b22c-93d5a12bd56f 35 fields · synced Jun 1, 2026