Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Afamin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- ALBUMIN STANDARD (1x 3mL) FDA UDI
- Model / Reference
- ALBS-3 FDA UDI
- Description
- ALBUMIN STANDARD (1x 3mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020661 FDA UDI
- 510(k) Number
- K822471 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Afamin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Afamin IVD, kit, nephelometry/turbidimetry
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Afamin IVD, kit, nephelometry/turbidimetry.
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
Cleared under the same submission
K822471 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- Albumin (w/ssa#) — POINTE SCIENTIFIC, INC.
- Albumin (w/ssa#) — POINTE SCIENTIFIC, INC.
- Albumin Std (w/ssa#) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Albumin — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Albumin Standard — POINTE SCIENTIFIC, INC.
- Pointe Albumin Reagent — POINTE SCIENTIFIC, INC.
- Pointe Albumin on BS480 Analyzer — POINTE SCIENTIFIC, INC.
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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 380000a8-7439-4a8b-a10e-81335a697dbe 36 fields · synced May 30, 2026