Identity
- Trade Name
- Redi-Check Photometer QC FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Device Name
- Photometer Quality Control FDA UDI
- Model / Reference
- Redi-Check Photometer QC FDA UDI
- Description
- Photometer Quality Control FDA UDI
Identifiers
- Catalog Number
- E305 FDA UDI
- Primary DI / UDI-DI
- 00850229007119 FDA UDI
- FDA Product Code
- JFS FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 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
Yes
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
No
FDA UDI
Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use
Redi-Check Photometer QC by Awareness Technology, Incorporated — Class II — 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.
- Neutral Density Densitometer Control for SPIFE 4000 — Helena Laboratories, Corp. · Class I
- RABS — Randox Laboratories, Ltd. · Class I
- SABS — Randox Laboratories, Ltd. · Class I
- AU — Beckman Coulter, Inc. · Class I
- Dimension Vista® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics · Class I
- Device Qualification Test Kit EUROLabLiquidHandler — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays — Helena Laboratories, Corp. · Class I
- BD Trucount™ — BECTON DICKINSON AND COMPANY · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Awareness Technology, Incorporated
Sources (1)
- FDA UDI dafabe22-5081-4406-95ab-43aff4874190 34 fields · synced May 31, 2026