FDA.reportPublic FDA data

Exact Diagnostics

Primary DI
00812242030116
Brand
Exact Diagnostics
Company
EXACT DIAGNOSTICS, LLC
Model
HBVP100
Catalog number
HBVP100
Device description
HBV Verification Panel
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812242030116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812242030116008122420301168122420301160812242030116

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core nucleic acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core nucleic acid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8179899262customerservice@exactdiagnostics.com

Regulatory Flags#

DUNS number
079898166
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522384372Exact Diagnostics12020068120200682024-08-27
03610522384389Exact Diagnostics12020069120200692024-08-27
00812242030901Exact DiagnosticsCOVFLUCOVFLU2022-06-17
00812242030918Exact DiagnosticsCOVFLUNEGCOVFLUNEG2022-06-17
00812242030840Exact DiagnosticsRPPOSRPPOS2019-12-12
00812242030857Exact DiagnosticsRPNEGRPNEG2019-12-12
00812242030758Exact DiagnosticsRPRCRPRC2019-09-19
03610522350773Exact Diagnostics12019432120194322023-05-09
00812242033759Exact DiagnosticsCTNGPOSCTNGPOS2022-09-30
00812242033766Exact DiagnosticsNEGSTINEGSTI2022-09-30
00812242030888Exact DiagnosticsCOV019CECOV019CE2022-06-17
00812242030895Exact DiagnosticsCOV000CECOV000CE2022-06-17
00812242031007Exact DiagnosticsHPVP200HPVP2002022-06-17
00812242031137Exact DiagnosticsNEGSYNNEGSYN2022-06-17
00812242031144Exact DiagnosticsNEGHAINEGHAI2022-06-17
00812242030123Exact DiagnosticsHBVL101HBVL1012018-09-24
00812242030130Exact DiagnosticsHBVH102HBVH1022018-09-24
00812242030222Exact DiagnosticsHBVAMRHBVAMR2018-09-24
00812242030673Exact DiagnosticsHBVP200HBVP2002018-09-24
00812242030680Exact DiagnosticsHBVL201HBVL2012018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336171516CalSet CalcitoninRoche Diagnostics GmbHJIT2026-06-01
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)Siemens Healthcare Diagnostics Inc.JIT2026-04-16
00630414622804Atellica IM CYFRA21-1 CalibratorSiemens Healthcare Diagnostics Inc.JIT2026-04-16
00816426021600K-ASSAY® Cystatin C CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJIT2026-04-16
08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185395454CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbHJIT2025-05-27
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
00811403011797ISE Calibrator LowDiamond Diagnostics Inc.JIT2023-06-05
00811403011810ISE Calibrator HighDiamond Diagnostics Inc.JIT2023-06-05
00811403013036Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
00811403013180Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
15099590702137Access Unconjugated Estriol CalibratorsBeckman Coulter, Inc.JIT2023-01-10
07613336166345CalSet beta-Amyloid (1-42) IIRoche Diagnostics GmbHJIT2022-12-13
00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
00630414610870Atellica CH LDLC CALSiemens Healthcare Diagnostics Inc.JIT2022-07-08
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
00630414607047DV/DM COV2G/CV2G CALSiemens Healthcare Diagnostics Inc.JIT2021-01-22
14987481100999NEFA Standard SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIT2020-10-23
00630414293523Atellica IM Calibrator 30Siemens Healthcare Diagnostics Inc.JIT2020-05-31
00630414279190Atellica CH UCFP CalibratorSiemens Healthcare Diagnostics Inc.JIT2020-03-09