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Audit MicroControls Control DROP LQ Blood Glucose
FDA UDIIdentity
- Trade Name
- Audit MicroControls Control DROP LQ Blood Glucose FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Model / Reference
- K078M-8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K078M80 FDA UDI
- GMDN Term
- Glucose 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, control
Audit MicroControls Control DROP LQ Blood Glucose by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, control.
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- Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd. · Class I
- TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
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
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI 9797db5b-69ff-453e-98f5-174c9052a0d4 32 fields · synced Jun 8, 2026