FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B645T0780
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
T0780
Device description
STERILE WATER 3ML
Published
2025-04-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B645T0780PrimaryHIBCC0
B645T07801Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Distilled sterile water suspension medium/diluent IVDA distilled sterile water solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.

Regulatory Flags#

DUNS number
047927827
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B6450715EDGE BIOLOGICALS INCT07152025-04-21
B6453P395EDGE BIOLOGICALS INC3P3952025-04-21
B645T0415EDGE BIOLOGICALS INCT04152025-04-21
B645T0453EDGE BIOLOGICALS INCT04532025-04-21
B645T0466EDGE BIOLOGICALS INCT04662025-04-21
B645T0481EDGE BIOLOGICALS INCT04812025-04-21
B645T0486EDGE BIOLOGICALS INCT04862025-04-21
B645T0488EDGE BIOLOGICALS INCT04882025-04-21
B645T0496EDGE BIOLOGICALS INCT04962025-04-21
B645T0577EDGE BIOLOGICALS INCT05772025-04-21
B645T0615EDGE BIOLOGICALS INCT06152025-04-21
B645T0641EDGE BIOLOGICALS INCT06412025-04-21
B645T0711EDGE BIOLOGICALS INCT07112025-04-21
B645T0713EDGE BIOLOGICALS INCT07132025-04-21
B645T0714EDGE BIOLOGICALS INCT07142025-04-21
B645T0718EDGE BIOLOGICALS INCT07182025-04-21
B645T0722EDGE BIOLOGICALS INCT07222025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLELonza VerviersPPM2026-03-30
05407010129861T-32 1000L bagLonza VerviersPPM2026-03-26
05407010129878T-32 200L bagLonza VerviersPPM2026-03-26
05407010129885NaAc-35 - 1000L bagLonza VerviersPPM2026-03-26
05407010129892NaAc-35 - 200L BagLonza VerviersPPM2026-03-26
05407010129908NaAc-35 -1L Sample bagLonza VerviersPPM2026-03-26
05407010129915NaP-55 - 1000LLonza VerviersPPM2026-03-26
05407010129922NaP-55 - 1L sample bagLonza VerviersPPM2026-03-26
05407010129939NaAc-36 -1000L BagLonza VerviersPPM2026-03-26
05407010129946NaAc-36 -1L Sample BagLonza VerviersPPM2026-03-26
05407010129953NaAc-36 -500L BagLonza VerviersPPM2026-03-26
05407010129960NaAc-34 -1000L BagLonza VerviersPPM2026-03-26
00630414289984Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414290034Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
04049016152019EUROSORB (IFA)EUROIMMUN Medizinische Labordiagnostika AGPPM2025-11-21
05407010129243KH-020 BF-1 1L Sample BagLonza VerviersPPM2025-10-30
05407010129250KH-020 BF-1 1000L BagLonza VerviersPPM2025-10-30
05407010129267KH-020 BF-1 500L BagLonza VerviersPPM2025-10-30
05407010129274NTT-001-L Buffer - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129311NTT-001-K : 1M NaCl - 200L bagLonza VerviersPPM2025-10-30
05407010129328NTT-001-K : 1M NaCl - 500L bagLonza VerviersPPM2025-10-30
05407010129335NTT-001-R : 150 mM NaCl - 1000L bagLonza VerviersPPM2025-10-30