Identity
- Trade Name
- KIT, SUCROSE, EASYSAMPLER, 7T, #8024 FDA UDI
- Generic Name
- Breath specimen container IVD FDA UDI
- Model / Reference
- QT04264 FDA UDI
Identifiers
- Catalog Number
- QT04264 FDA UDI
- Primary DI / UDI-DI
- 00850010197715 FDA UDI
- FDA Product Code
- NNI FDA UDI
- GMDN Term
- Breath specimen container IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
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
Yes
FDA UDI
Category: Breath specimen container IVD
Kit, Sucrose, Easysampler, 7t, #8024 by Quintron Instrument Co. Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breath specimen container IVD.
- KIT, GLUCOSE, EASYSAMPLER, 10T SIBO #8024 — QUINTRON INSTRUMENT CO. INC. · Class I
- EasySampler, Glucose Kit, 10 Tubes — QUINTRON INSTRUMENT CO. INC. · Class I
- SUGAR, D-XYLOSE, 25 GM, PACKET — QUINTRON INSTRUMENT CO. INC. · Class I
- MOUTHPIECE, 20 MM, PLASTIC — QUINTRON INSTRUMENT CO. INC. · Class I
- KIT, Rx, LACTULOSE, SIBO, 10T #8024 — QUINTRON INSTRUMENT CO. INC. · Class I
- EasySampler, No Substrate Kit, 7 Tube — QUINTRON INSTRUMENT CO. INC. · Class I
- EasySampler, Lactulose Kit, 10 Tubes, Rx — QUINTRON INSTRUMENT CO. INC. · Class I
- EasySampler, Fructose Kit, 4 Tubes — QUINTRON INSTRUMENT CO. 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
- Quintron Instrument Co. Inc.
Sources (1)
- FDA UDI d0109309-4235-4cb0-a320-6c545be40638 33 fields · synced May 30, 2026