FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647025277
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
FH2460-605
Catalog number
23001178
Device description
BHB TRI-LEVEL CONTROL
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIFDrug mixture control materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647025271PackageGS11In Commercial Distribution
00613647025277PrimaryGS10
10613647025274Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702527120613647025271
00613647025277006136470252776136470252770613647025277
1061364702527410613647025274

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-1500regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690286000742MEDTOX®MEDTOX DIAGNOSTICS, INC.DIF2026-03-31
00810042684416DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684423DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684430DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684447DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684270DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684287DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684294DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684300DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684317DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684249DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684256DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
00810042683976DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683983DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683990DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684010DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684027DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684034DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684041DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684058DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684065DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12