Identity
- Trade Name
- JAS Diagnostics, inc FDA UDI
- Generic Name
- Magnesium (Mg2+) IVD, calibrator FDA UDI
- Device Name
- Magnesium Standard Liquid Bulk FDA UDI
- Model / Reference
- MAGS-BUL FDA UDI
- Description
- Magnesium Standard Liquid Bulk FDA UDI
Identifiers
- Catalog Number
- MAGS-BUL FDA UDI
- Primary DI / UDI-DI
- 00817274022405 FDA UDI
- 510(k) Number
- K853592 FDA UDI
- FDA Product Code
- JGJ FDA UDI
- GMDN Term
- Magnesium (Mg2+) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1495 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Liter FDA UDI
Category: Magnesium (Mg2+) IVD, calibrator
JAS Diagnostics, inc by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Magnesium (Mg2+) IVD, calibrator.
Cleared under the same submission
K853592 also covers:
- Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Magnesium Reagent — POINTE SCIENTIFIC, INC.
- Pointe Magnesium Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Magnesium Std — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 2f638421-3c29-45b7-8378-189eb9f6a634 38 fields · synced May 30, 2026