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FDA Approval

Leukotrap WB System

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Haemonetics Corporation
DUNS: 057827420
Effective Date
July 19, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Glucose(2.01 g in 63 mL)
Sodium citrate(1.66 g in 63 mL)
VS-01(0.206 g in 63 mL)
Sodium phosphate, dibasic(0.14 g in 63 mL)
Adenine(0.017 g in 63 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Haemonetics Manufacturing Inc

Haemonetics Corporation

078598396

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Leukotrap WB System

Product Details

NDC Product Code
53157-736
Application Number
BN800077
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
July 19, 2023
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.01 g in 63 mL
Sodium citrateActive
Code: 1Q73Q2JULRClass: ACTIBQuantity: 1.66 g in 63 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.206 g in 63 mL
Sodium phosphate, dibasicActive
Code: 593YOG76RNClass: ACTIBQuantity: 0.14 g in 63 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.017 g in 63 mL
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