Identity
- Trade Name
- Monobind AccuBind PRL ELISA Kit - 96 Wells FDA UDI
- Generic Name
- Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay FDA UDI
- Model / Reference
- 725-300 FDA UDI
Identifiers
- Catalog Number
- 725-300A FDA UDI
- Primary DI / UDI-DI
- 00816870021027 FDA UDI
- 510(k) Number
- K971921 FDA UDI
- FDA Product Code
- CFT FDA UDI
- GMDN Term
- Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1625 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 — 7.75 Inch FDA UDI
Category: Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay
Monobind AccuBind PRL ELISA Kit - 96 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K971921 also covers:
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
- Monobind, Inc.
Sources (1)
- FDA UDI 4f79d15e-1ecb-4b77-bcb4-2755e6b09982 37 fields · synced May 30, 2026