FDA UDI
In Commercial Distribution
🇺🇸 United States
HALO AP Dx
DI: G264APDX240
·
Model: 2.4
·
Indica Labs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HALO AP Dx
- Primary DI
- G264APDX240
- Version / Model
- 2.4
- Company Name
- Indica Labs, Inc.
- Labeler DUNS
- 048372644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-27
- Public Version
- 1
- Public Version Date
- 2026-04-06
- Public Version Status
- New
- Public Device Record Key
- 9c524b15-eac5-4b7f-a53c-86d8b26bcc06
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QKQ | Digital Pathology Image Viewing And Management Software | Pathology | 864.3700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44103 | Pathology information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. It is typically supplied for installation into a dedicated pathology information system or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G264APDX240 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252762 | 000 |