FDA.reportPublic FDA data

ACU-NICKERSON

Primary DI
00814105021231
Brand
ACU-NICKERSON
Company
ACUDERM, INC.
Model
M104
Device description
ACU-NICKERSON, 24/Bx
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832581000DTM-DERMATOPHYTE TEST MEDIUMAcuderm, Inc.1983-09-12JSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814105021238PrimaryGS10
00814105021231Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081410502123810814105021238
00814105021231008141050212318141050212310814105021231

GMDN Terms#

Term, Definition table
TermDefinition
Candida albicans microbial identification reagent IVDA substance or reactant containing serum, intended to be used in microbial testing to perform a germ tube test for the identification of Candida albicans isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071426803
Device count
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020005Acu-Dispo-CuretteR012020-09-22
00814105020012Acu-Dispo-CuretteR022020-09-22
00814105020029Acu-Dispo-CuretteR032020-09-22
00814105020036Acu-Dispo-CuretteR042020-09-22
00814105020043Acu-Dispo-CuretteR052020-09-22
00814105020050Acu-Dispo-CuretteR072020-09-22
00814105021316Acu-Dispo-CuretteRCOM2020-09-22
00814105021323Acu-Dispo-CuretteRCOMPL2020-09-22
00814105020876ACU-GUARD0ADG51S2020-01-03
10814105020873ACU-GUARDADG51S2020-01-03
10814105021108Acu-ScissorsSCS2020-09-22
10814105021115Acu-ScissorsSCC2020-09-22
10814105021207ACU-DTMM1012020-09-22
10814105021214ACU-DTMM1012020-09-22
10814105021221ACU-SABOURAUDM1032020-09-22
10814105021238ACU-NICKERSONM1042020-09-22
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B6453P395EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B6451R009EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P275EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P390EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
00848838001055REMELREMEL, INC.JSJ2023-01-03
00848838001086REMELREMEL, INC.JSJ2023-01-03
00848838001093REMELREMEL, INC.JSJ2023-01-03
00848838001116REMELREMEL, INC.JSJ2023-01-03
00848838001437REMELREMEL, INC.JSJ2023-01-03
00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30