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 a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma. FDA UDI
- Model / Reference
- 0066908 FDA UDI
- Description
- Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- 0066908 FDA UDI
- Primary DI / UDI-DI
- 10888234002291 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
Yes
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
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 540c862a-d4b1-41b4-b3e1-f5dea99e519b 35 fields · synced May 30, 2026