Identity
- Trade Name
- Capture LISS FDA UDI
- Generic Name
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
- Device Name
- Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with ten vials packaged. FDA UDI
- Model / Reference
- 0006420 FDA UDI
- Description
- Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with ten vials packaged. FDA UDI
Identifiers
- Catalog Number
- 0006420 FDA UDI
- Primary DI / UDI-DI
- 10888234000587 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 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
Yes
FDA UDI
Prescription Use
Yes
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
Category: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Capture LISS by Immucor, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.
- IH-LISS Rack — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- ALBAhance LISS Additive Reagent — ALBA BIOSCIENCE LIMITED · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- LISS — DIAGAST · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
BK860017 also covers:
- Capture LISS — IMMUCOR, INC.
- Capture LISS — IMMUCOR, INC.
- Capture LISS — IMMUCOR, INC.
- Capture LISS — IMMUCOR, INC.
- Capture-P — IMMUCOR, INC.
- Capture-P Control set — IMMUCOR, INC.
- Capture-P Indicator Red Cells — IMMUCOR, INC.
- Capture-P Indicator Red Cells — IMMUCOR, INC.
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum — IMMUCOR, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI b29c7aba-ab81-4983-8935-149d742db5dc 37 fields · synced Jun 1, 2026