Identity
- Trade Name
- ASFA® SPOTTER FDA UDI
- Generic Name
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
- Device Name
- ASFA SPOTTER: It is used to precisely and accurately dispense biological samples such as cells, drugs, and viruses into well plates and microchips. FDA UDI
- Model / Reference
- MBD-SP-ST006 FDA UDI
- Description
- ASFA SPOTTER: It is used to precisely and accurately dispense biological samples such as cells, drugs, and viruses into well plates and microchips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066300111 FDA UDI
- FDA Product Code
- JTC FDA UDI
- GMDN Term
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2500 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 1045 Millimeter FDA UDIDepth — 600 Millimeter FDA UDIHeight — 618 Millimeter FDA UDI
Category: Microbial specimen inoculation/streaking/colony-picking instrument IVD
Asfa® Spotter by MBD CO., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microbial specimen inoculation/streaking/colony-picking instrument IVD.
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- ASFA SPOTTER — MBD 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 |
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Manufacturer
- Manufacturer
- MBD CO., Ltd.
Sources (1)
- FDA UDI 2999dc82-eef6-467a-aec4-85f36057a0d6 36 fields · synced May 29, 2026