FDA.reportPublic FDA data

SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit

Primary DI
00817830022535
Brand
SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit
Company
MP BIOMEDICALS, LLC
Model
06B257117
Catalog number
06B257117
Device description
Radioimmunoassay for the quantitative determination of Vitamin B12/Folate in human plasma or serum.
Published
2016-10-20
Public version status
Update
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
CDDRADIOASSAY, VITAMIN B12

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDDRadioassay, Vitamin B12Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822721000NO-BOIL SOLID PHASE SIMUL TRAC B12Bd Becton Dickinson Vacutainer Systems Preanalytic1983-03-10CDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022535008178300225358178300225350817830022535

GMDN Terms#

Term, Definition table
TermDefinition
Vitamin B12 IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of vitamin B12 in a clinical specimen, using a radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
137825928
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830023211MP Biomedicals LLC07189105071891052023-08-03
00817830023228MP Biomedicals LLC07596303075963032023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
00817830023143MP Biomedicals LLC07152101071521012023-08-02
00817830023150MP Biomedicals LLC07171102071711022023-08-02
00817830023167MP Biomedicals LLC07170102071701022023-08-02
00817830023174MP Biomedicals LLC07170105071701052023-08-02
00817830023181MP Biomedicals LLC07270102072701022023-08-02
00817830023198MP Biomedicals LLC07270105072701052023-08-02
00817830023204MP Biomedicals LLC07189102071891022023-08-02
00817830023013MP Biomedicals LLC07109202071092022023-08-01
00817830023020MP Biomedicals LLC07230102072301022023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740189785AlinityAbbott GmbHCDD2026-01-01
00380740189792ARCHITECTAbbott GmbHCDD2026-01-01
00380740189808ARCHITECTAbbott GmbHCDD2026-01-01
00380740189815AlinityAbbott GmbHCDD2026-01-01
15099590224301Access Vitamin B12Beckman Coulter, Inc.CDD2025-09-09
00630414600307Atellica IM VB12 MCMSiemens Healthcare Diagnostics Inc.CDD2020-09-24
00630414293554Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414293820Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294100Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294261Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
08056771602532LIAISON® Vitamin B12Diasorin Inc.CDD2019-12-04
00380740150525AlinityAbbott GmbHCDD2019-06-07
00816870020280Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870020297Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870020365Vit B12 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870020372Vit B12 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870021966Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870021973Monobind AccuLite Folate & Vit B12 VAST CLIA Kit - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870022048Vit B12 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870022055Vit B12 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00380740136703AlinityABBOTT IRELANDCDD2019-01-02
00380740136697AlinityABBOTT IRELANDCDD2018-11-12
00630414245720Atellica IM AB12Siemens Healthcare Diagnostics Inc.CDD2018-10-19
00630414598611Atellica IM CKMB MCMSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600277Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600284Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600291Atellica IM VB12 DILSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600314Atellica IM VB12 DTT/RELSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414598338Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2017-12-27
00630414598345Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2017-12-22