Identity
- Trade Name
- Pointe Carbon Dioxide Reagent FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Carbon Dioxide Reagent packaged for use on the Mindray BA800. 4 x 45ml. For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 16-C7502-180 FDA UDI
- Description
- Pointe Carbon Dioxide Reagent packaged for use on the Mindray BA800. 4 x 45ml. For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 16-C7502-180 FDA UDI
- Primary DI / UDI-DI
- 00811727016102 FDA UDI
- 510(k) Number
- K070251 FDA UDI
- FDA Product Code
- KHS FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1160 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: Carbon dioxide (CO2) IVD, kit, spectrophotometry
Pointe Carbon Dioxide Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide (CO2) IVD, kit, spectrophotometry.
- ADVIA Chemistry CO2_c — Siemens Healthcare Diagnostics · Class II
- ADVIA® Chemistry CO2_c Reagents Concentrated — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Yumizen C1200 CO2 — Horiba Abx · Class II
- Bicarbonate Liquid — Roche Diagnostics Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K070251 also covers:
- POINTE SCIENTIFIC CO2 — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable — POINTE SCIENTIFIC, INC.
- Pointe Carbon Dioxide on the BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Carbon Dioxide — 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 f8af0e44-d67a-443b-9622-1650077c96ea 37 fields · synced Jun 6, 2026