Identity
- Trade Name
- C.D.RICH FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit FDA UDI
- Device Name
- This product is used for the collection, transferring and storage of specimen in labs/hospitals. FDA UDI
- Model / Reference
- Is-I 3ml FDA UDI
- Description
- This product is used for the collection, transferring and storage of specimen in labs/hospitals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16935238804148 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection kit 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
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
Yes
FDA UDI
Category: Oral/upper respiratory tract specimen collection kit
C.d.rich by Chengdu Rich Science Industry Co., Ltd. — 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
- Chengdu Rich Science Industry Co., Ltd.
Sources (1)
- FDA UDI f988c11d-8be0-4209-afec-41399dc5593e 33 fields · synced Jun 1, 2026