← Back to catalogue
Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche Systems
FDA UDIIdentity
- Trade Name
- Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche Systems FDA UDI
- Generic Name
- Total bilirubin IVD, control FDA UDI
- Model / Reference
- K919M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K919M50 FDA UDI
- GMDN Term
- Total bilirubin 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: Total bilirubin IVD, control
Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche Systems by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total bilirubin IVD, control.
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- BILIRUBIN ELEVATED SERUM (BIL CONTROL H) — Randox Laboratories, Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Pediatric Bilirubin Control Level 1&2 Set 2x3mL — QUANTIMETRIX CORP. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI acda54b2-e7f4-4788-9156-3fec31642dce 32 fields · synced May 30, 2026