Identity
- Trade Name
- Immco FDA UDI
- Generic Name
- Buffered wash solution IVD, manual FDA UDI
- Device Name
- Wash Buffer Concentrate FDA UDI
- Model / Reference
- 230AWI FDA UDI
- Description
- Wash Buffer Concentrate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391516747493 FDA UDI
- 510(k) Number
- K954723 FDA UDI
- FDA Product Code
- LKJ FDA UDI
- GMDN Term
- Buffered wash solution IVD, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Buffered wash solution IVD, manual
Immco by Clark Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD, manual.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- TRIS WASH BUFFER — Biogenex Laboratories, Inc. · Class I
- EUROArray wash buffer set — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Bio-Rad — Bio-Rad Laboratories · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
Cleared under the same submission
K954723 also covers:
- 96AN — Bio-Rad Laboratories
- 96AN — Bio-Rad Laboratories
- ANA PLATE — Bio-Rad Laboratories
- ANA PLATE — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Immco Diagnostics — CLARK LABORATORIES, INC.
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI da4ba67a-d308-4ac9-89e1-c8619eac5f9d 37 fields · synced May 30, 2026