Identity
- Trade Name
- 903 DBS Collection Cards - 5 Samples FDA UDI
- Generic Name
- Dried blood spot collection card IVD FDA UDI
- Model / Reference
- 621MM FDA UDI
Identifiers
- Catalog Number
- 621MM FDA UDI
- Primary DI / UDI-DI
- 00816870021300 FDA UDI
- FDA Product Code
- PJC FDA UDI
- GMDN Term
- Dried blood spot collection card IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
Dimensions & Sizes
- Size
- Width — 3 Inch FDA UDI
Category: Dried blood spot collection card IVD
903 DBS Collection Cards - 5 Samples by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 903 DBS Collection Cards - 6 Samples — MONOBIND, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 3fdbbe29-049d-40ab-bc42-0c07bd9a7264 35 fields · synced Jun 8, 2026