Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Device Name
- Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and recalcification (plasma clotting) time, as well as in various coagulation factor assays FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and recalcification (plasma clotting) time, as well as in various coagulation factor assays FDA UDI
Identifiers
- Catalog Number
- HC301 FDA UDI
- Primary DI / UDI-DI
- 00850053916205 FDA UDI
- 510(k) Number
- K020840 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Calcium chloride coagulation reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 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
Yes
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
Category: Calcium chloride coagulation reagent IVD
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Calcium chloride coagulation reagent IVD.
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- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
- Calcium Chloride Solution — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- .02M Calcium Chloride — Analytical Control Systems · Class II
- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 599ce6d5-2b8a-41d3-ba77-b5d079abbb85 36 fields · synced Jun 8, 2026