Identity
- Trade Name
- Calcium chloride 0.025M (M/40) FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Model / Reference
- AR001K FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663537008467 FDA UDI
- GMDN Term
- Calcium chloride coagulation reagent IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
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
Calcium chloride 0.025M (M/40) by Hyphen Biomed — 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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- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- QuikCoag Calcium Choride 0.02M — Biomedica Diagnostics Inc · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Hyphen Biomed
Sources (1)
- FDA UDI 38deaf9e-57ea-4630-9935-848c339f7053 33 fields · synced Jun 1, 2026