Identity
- Trade Name
- Neutral Density Densitometer Control for QuickScan FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Model / Reference
- 1031000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52510310000 FDA UDI
- FDA Product Code
- JQJ FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1630 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use
Neutral Density Densitometer Control for QuickScan by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical laboratory instrument performance standard calibrator/control IVD, single-use.
- RABS — Randox Laboratories, Ltd. · Class I
- SABS — Randox Laboratories, Ltd. · Class I
- Redi-Check Photometer QC — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- AU — Beckman Coulter, Inc. · Class I
- DriDye 450 — AWARENESS TECHNOLOGY, INCORPORATED · Class I
- Dimension Vista® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics · Class I
- Device Qualification Test Kit EUROLabLiquidHandler — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- DriDye 405 — AWARENESS TECHNOLOGY, INCORPORATED · 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI ff433b46-874e-47f0-975a-a3d930b337f9 33 fields · synced Jun 9, 2026