Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- HEMOGLOBIN A1C CONTROLS (1x 0.5mL L1, 1x 0.5mL L2) FDA UDI
- Model / Reference
- A1CC1-0.5 FDA UDI
- Description
- HEMOGLOBIN A1C CONTROLS (1x 0.5mL L1, 1x 0.5mL L2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021743 FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, control
JAS Diagnostics by Drew Scientific , Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
- IDG/Sanzay — IDG/SANZAY Corporation · 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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 88af9dca-fc58-4526-866c-9f0f45291157 35 fields · synced Jun 1, 2026