Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Glucose IVD, kit, spectrophotometry FDA UDI
- Device Name
- Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only. 1 x 1L FDA UDI
- Model / Reference
- G7521-1L FDA UDI
- Description
- Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only. 1 x 1L FDA UDI
Identifiers
- Catalog Number
- G7521-1L FDA UDI
- Primary DI / UDI-DI
- 00811727011282 FDA UDI
- 510(k) Number
- K970781 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Glucose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, kit, spectrophotometry
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, kit, spectrophotometry.
- ADVIA® Chemistry GLUO Glucose Oxidase Reagents — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208 — Carolina Liquid Chemistries Corp. · Class II
- Yumizen C1200 Glucose HK — Horiba Abx · Class II
- Atellica CH GluO — Siemens Healthcare Diagnostics · Class II
- Glucose HK — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc. · Class II
- Dimension Vista® Flex® reagent cartridge GLU — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K970781 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Glucose Ox — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Glucose Ox — 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI d6c70a35-b370-47c4-a5e7-7cd0f6882fef 37 fields · synced Jun 8, 2026