Identity
- Trade Name
- ID NOW™ Instrument FDA UDI
- Generic Name
- Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays. FDA UDI
- Model / Reference
- EQ00200XS FDA UDI
- Description
- The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877010616 FDA UDI
- 510(k) Number
- K141520 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isothermal nucleic acid amplification analyser IVD, laboratory
ID NOW™ Instrument by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isothermal nucleic acid amplification analyser IVD, laboratory.
- Solana — Quidel Corp. · Class II
- illumipro-10 — MERIDIAN BIOSCIENCE, INC. · Class II
- Panther® — Hologic, Inc. · Class II
- BD MicroProbe™ Processor — BECTON DICKINSON AND COMPANY · Class I
- BD Microprobe™ Processor — BECTON DICKINSON AND COMPANY · Class I
- BD MicroProbe™ Processor — BECTON DICKINSON AND COMPANY · Class I
- ID NOW™ Instrument — Alere Scarborough, Inc. · Class II
- Alere™ i Instrument — Alere Scarborough, Inc. · Class II
Cleared under the same submission
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
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI da6e9cb5-fec5-4f37-a74a-732f4e2acdbf 34 fields · synced May 30, 2026