Identity
- Trade Name
- Gongdong FDA UDI
- Generic Name
- Clinical specimen extraction buffer IVD FDA UDI
- Device Name
- Quantisal Expressor Push Cap FDA UDI
- Model / Reference
- G2007 FDA UDI
- Description
- Quantisal Expressor Push Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947462403748 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Clinical specimen extraction buffer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Clinical specimen extraction buffer IVD
A buffered solution used for the processing and preparation of clinical specimens, intended for subsequent in vitro diagnostic testing. It is an implantable device that extracts specific target analytes from a clinical specimen.
Similar devices
Also classified as Clinical specimen extraction buffer IVD.
- Extraction Buffer 4X, 225mL Fill — American Laboratory Products Company · Class I
- LIAISON Q.S.E.T. Buffer — Diasorin Inc.
- Easy Stool Extraction Device — American Laboratory Products Company · Class I
- VITROS — Ortho-Clinical Diagnostics · N
- Extraction Buffer 4X, 55mL Fill — American Laboratory Products Company · Class I
- Extraction kit - 3 buffer containers — Bühlmann Laboratories AG
- Extraction Kit - 12 buffer containers — Bühlmann Laboratories AG
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · 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
- Zhejiang Gongdong Medical Technology Co., Ltd.,
Sources (1)
- FDA UDI 976dba21-fe64-425e-bc25-1f91aa26d275 33 fields · synced Jul 18, 2026