Identity
- Trade Name
- Validate FDA UDI
- Generic Name
- Calcitonin IVD, control FDA UDI
- Device Name
- VALIDATE CT Calibration Verification/Linearity Test Kit FDA UDI
- Model / Reference
- 907re FDA UDI
- Description
- VALIDATE CT Calibration Verification/Linearity Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135648 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Calcitonin 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
No
FDA UDI
Category: Calcitonin IVD, control
Validate by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcitonin IVD, control.
- Calcitonin control slides — BIO SB, INC. · Class I
- Calcitonin Control Slides — BIO SB, INC. · Class I
- Atellica IM Calcitonin MCM — Siemens Healthcare Diagnostics · Class I
- IMMULITE® Systems CONTROL Calcitonin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Calcitonin Control Slides — BIO SB, INC. · Class I
- ADVIA Centaur Calcitonin MCM — Siemens Healthcare Diagnostics · 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
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI 9f1bfa9e-a28d-4d9a-b571-ae5bd858023b 35 fields · synced Jun 9, 2026