Identity
- Trade Name
- Monobind Qsure Maternal Control Set FDA UDI
- Generic Name
- Trisomy 21-risk hormone IVD, control FDA UDI
- Model / Reference
- MC-300 FDA UDI
Identifiers
- Catalog Number
- MC-300 FDA UDI
- Primary DI / UDI-DI
- 00816870020204 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Trisomy 21-risk hormone IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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 — 2 Inch FDA UDI
Category: Trisomy 21-risk hormone IVD, control
Monobind Qsure Maternal Control Set by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trisomy 21-risk hormone IVD, control.
- MATERNAL CONTROL - LEVEL 1 (MATERNAL CONTROL 1) — Randox Laboratories, Ltd. · Class I
- MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2) — Randox Laboratories, Ltd. · Class I
- MATERNAL CONTROL - LEVEL 3 (MATERNAL CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Monobind Qsure Tumor Marker Control Set — MONOBIND, INC. · 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
- Monobind, Inc.
Sources (1)
- FDA UDI 60d2c160-7d18-4d4a-b437-fc91c50705f1 36 fields · synced Jun 1, 2026