FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647025295
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
FH2450-604
Catalog number
23001180
Device description
BHB LINEARITY STDS
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKBCalibrators, drug mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647025295PackageGS11In Commercial Distribution
00613647025291PrimaryGS10
10613647025298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702529520613647025295
00613647025291006136470252916136470252910613647025291
1061364702529810613647025298

GMDN Terms#

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

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 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
00840937114636ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114643ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114650ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114667ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
00840937112083ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112090ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112106ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112113ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00811727016850Pointe Universal Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017550Pointe Multi-Analyte Set C Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017567Pointe Multi-Analyte Set C Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017628Pointe Multi-Analyte Set D Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017642Pointe Multi-Analyte Set D Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017727Pointe Multi-Analyte E DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00380740179342AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179359AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179366AlinityABBOTT LABORATORIESDKB2020-05-11
00840937111895ImmunalysisIMMUNALYSIS CORPDKB2020-03-31
00840937111918ImmunalysisIMMUNALYSIS CORPDKB2020-03-31
00840937111925ImmunalysisIMMUNALYSIS CORPDKB2020-03-31