Identity
- Trade Name
- Mycobacti-Loops FDA UDI
- Generic Name
- Culture medium control FDA UDI
- Device Name
- P. mirabilis ATCC 12453 CFUrine KT/2 TST FDA UDI
- Model / Reference
- R4702000 FDA UDI
- Description
- P. mirabilis ATCC 12453 CFUrine KT/2 TST FDA UDI
Identifiers
- Catalog Number
- R4702000 FDA UDI
- Primary DI / UDI-DI
- 00848838042836 FDA UDI
- FDA Product Code
- JTR FDA UDI
- GMDN Term
- Culture medium control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Culture medium control
Mycobacti-Loops by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- REMEL — REMEL, INC. · Class I
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- REMEL — REMEL, 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 |
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Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 048c147a-0bc1-441e-80de-1921c61a9c6c 34 fields · synced Jun 6, 2026