Lonza Walkersville Inc

FDA Filings

This page includes the latest FDA filings for Lonza Walkersville Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Lonza Walkersville Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3006158025
FEI Number3006158025
NameSANGEETHA RAJESH
Owner & OperatorLONZA WALKERSVILLE, INC.
Contact Address8830 BIGGS FORD RD --
Walkersville MD 21793 US
Official Correspondent
  • SANGEETHA RAJESH
  • x-301-3781276-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8830 BIGGS FORD RD.
Walkersville, MD 21793 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number1114298
FEI Number1114298
NameLONZA WALKERSVILLE, INC.
Owner & OperatorLONZA WALKERSVILLE, INC.
Contact Address8830 BIGGS FORD RD --
Walkersville MD 21793 US
Official Correspondent
  • SANGEETHA RAJESH
  • x-301-3781276-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8830 Biggs Ford Rd
WALKERSVILLE, MD 21793 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Lonza Walkersville, Inc.
CHO Medium 4A, 8902g 003110452024-04-04
Lonza Walkersville, Inc.
UltraCulture WVSP1104P2002024-03-20
Lonza Walkersville, Inc.
UltraCulture WVSP1104P202024-03-20
Lonza Walkersville, Inc.
UltraCulture WVSP1104P0.52024-03-20
Lonza Walkersville, Inc.
TheraPEAK® MSCGM® Supplement BP13-935J2023-11-23
Lonza Walkersville, Inc.
1X PBS, pH 7.4 200L 08-975E2023-08-09
Lonza Walkersville, Inc.
Formulation Buffer (pH 7.40 + 0.20) 04-1250Q (00307661)2023-08-04
Lonza Walkersville, Inc.
Diafiltration Buffer 2023-08-04
Lonza Walkersville, Inc.
1.2M Magnesium Sulfate 04-1249L (00307650)2023-08-04
Lonza Walkersville, Inc.
PBS 04-1248F (00307649)2023-08-04
Lonza Walkersville, Inc.
0.6M Sodium Butyrate 2023-08-04
Lonza Walkersville, Inc.
2X HBS Buffer (pH 7.30 + 0.10) 04-1246Q (00307647)2023-08-04
Lonza Walkersville, Inc.
2M Calcium Chloride 04-1245L (00307646)2023-08-04
Lonza Walkersville, Inc.
TE Buffer (pH 7.90 + 0.30) 04-1244Q (00307645)2023-08-04
Lonza Walkersville, Inc.
TheraPEAK® X-VIVO® 15 without Gentamycin or Phenol Red 08-988H2023-06-26
Lonza Walkersville, Inc.
Feed Base J (BESP901) Customer Sample 15-1006XS2023-06-08
Lonza Walkersville, Inc.
Feed Base G (BESP899) Customer Sample 15-1004XS2023-06-08
Lonza Walkersville, Inc.
Feed Base H (BESP900) Customer Sample 15-1005XS2023-06-08
Lonza Walkersville, Inc.
CHO Vitamin Mix BESP808 Customer Sample 15-1007XS2023-06-08
Lonza Walkersville, Inc.
CHO Trace Element Solution (BESP807) 04-1163Q2023-05-15
Lonza Walkersville, Inc.
UltraMDCK Serum-Free Medium BP12-749Q2023-05-03
Lonza Walkersville, Inc.
TheraPEAK X-Vivo 10 Contains Recombinant Transferrin BP02-055Q2023-04-21
Lonza Walkersville, Inc.
CEF-01, 146mM Sucrose, 50mM NaCl, 15mM Na2HPO4, 5mM KHPO4, pH 7.2 08-986B2023-03-08
Lonza Walkersville, Inc.
CEF-04, 146mM Sucrose, 100mM NaCl, 15mM Na2HPO4, 5mM KHPO4, pH 7.2 08-985F2023-03-08
Lonza Walkersville, Inc.
X-VIVO 10 without Gentamycin without Phenol Red 08-979Y2023-02-10
SANGEETHA RAJESH [LONZA WALKERSVILLE, INC.]
Mycoplasma Detection Kit2019-03-04
LONZA WALKERSVILLE, INC.
Mycoplasma Detection Kit2019-03-04
SANGEETHA RAJESH [LONZA WALKERSVILLE, INC.]
Laboratory Equipment2019-02-25
LONZA WALKERSVILLE, INC.
Laboratory Equipment2019-02-25
SANGEETHA RAJESH [LONZA WALKERSVILLE, INC.]
Culture Media Supplement2019-02-25
LONZA WALKERSVILLE, INC.
Culture Media Supplement2019-02-25
LONZA WALKERSVILLE, INC.
Media and Components1978-03-15
LONZA WALKERSVILLE, INC.
ANIMAL AND HUMAN SERA1978-03-15
LONZA WALKERSVILLE, INC.
BALANCED SALT SOLUTIONS1978-03-15

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