Identity
- Trade Name
- Osmolarity High Control Solution FDA UDI
- Generic Name
- Osmolality IVD, control FDA UDI
- Model / Reference
- 100013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853539002058 FDA UDI
- GMDN Term
- Osmolality IVD, control 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
Yes
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
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: Osmolality IVD, control
Osmolarity High Control Solution by Tearlab Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osmolality IVD, control.
- Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottle — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 200 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 300 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 — Advanced Instruments, LLC · Class I
- Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Precision Systems CON-TROL 290, 5 ml ampules, 12/pk — PRECISION SYSTEMS, INC. · Class I
- Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Precision Systems 600 mOsm Osmometry Standard — PRECISION SYSTEMS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tearlab Corporation
Sources (1)
- FDA UDI 8768574d-629c-480b-8ace-736bbda37b97 32 fields · synced May 30, 2026