FDA.report

EDGE BIOLOGICALS INC

Primary DI
B6454P1561
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
4P156
Device description
DTM AGAR 60X100
Published
2025-04-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JSICulture Media, Selective And Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6454P156PrimaryHIBCC0
B6454P1561Unit of UseHIBCC0

GMDN Terms

TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
047927827
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B64507151EDGE BIOLOGICALS INCT07152025-04-21
B6453P3951EDGE BIOLOGICALS INC3P3952025-04-21
B645GB123EDGE BIOLOGICALS INCGB1232025-04-21
B645MR115EDGE BIOLOGICALS INCMR1152025-04-21
B645SB100DEF1EDGE BIOLOGICALS INCSB100DEF2025-04-21
B645SB50DEF1EDGE BIOLOGICALS INCSB50DEF2025-04-21
B645T04151EDGE BIOLOGICALS INCT04152025-04-21
B645T04531EDGE BIOLOGICALS INCT04532025-04-21
B645T04661EDGE BIOLOGICALS INCT04662025-04-21
B645T04811EDGE BIOLOGICALS INCT04812025-04-21
B645T04861EDGE BIOLOGICALS INCT04862025-04-21
B645T04881EDGE BIOLOGICALS INCT04882025-04-21
B645T04961EDGE BIOLOGICALS INCT04962025-04-21
B645T05771EDGE BIOLOGICALS INCT05772025-04-21
B645T06151EDGE BIOLOGICALS INCT06152025-04-21
B645T06411EDGE BIOLOGICALS INCT06412025-04-21
B645T07111EDGE BIOLOGICALS INCT07112025-04-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842558116709Spectra™ Candida Agar REMEL, INC.JSI2026-02-09
00810144911526RediporAnalytiChem USA, Inc.JSI2026-01-27
00848838003158Strep Selective II AgarREMEL, INC.JSI2026-01-16
00810144911472RediporAnalytiChem USA, Inc.JSI2025-11-26
B645GB123EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T04961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T05771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T07621EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B6454P2901EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3601EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P4011EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454Q1941EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454T2071EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T04321EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6451P2061EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R1111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R1801EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6453P1401EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P1551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P3751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P3761EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B645T02361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
00810144911359Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSI2025-01-12
05032384082919ORSAB SELECTIVE SUPPLEMENTOXOID LIMITEDJSI2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASEOXOID LIMITEDJSI2024-10-29
30382902978825BD BBL™ Pseudosel™ Agar (Cetrimide Agar)BECTON, DICKINSON AND COMPANYJSI2024-09-19
30382902149829BD BBL™ CHROMagar™ Staph aureusBECTON, DICKINSON AND COMPANYJSI2024-08-28
05032384002092Desoxycholate Citrate Agar (Hynes)OXOID LIMITEDJSI2024-08-13