Alpha-Tec Systems

Primary DI
00816085023861
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003470
Device description
Bovine Albumin Fraction V 10x10ml
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JSYKit, Identification, Mycobacteria

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSYKit, Identification, MycobacteriaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880990000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880990000ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTIONAlpha-Tec Systems, Inc.1988-03-24JSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023861008160850238618160850238610816085023861

GMDN Terms#

Term, Definition table
TermDefinition
Sputum specimen liquefaction/decontamination kit IVDA collection of reagents and other associated materials intended to be used alone or in combination with other IVDs for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory disease (e.g., Streptococcus pneumoniae, Mycobacterium tuberculosis) in preparation for further processing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103105524
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816085020549Alpha-Tec Systems000032482022-08-11
00816085020921Alpha-Tec Systems000043022022-08-11
00816085020938Alpha-Tec Systems000043032022-08-11
00816085020945Alpha-Tec Systems000043042022-08-11
00816085020952Alpha-Tec Systems000043052022-08-11
00816085020969Alpha-Tec Systems000043062022-08-11
00816085020976Alpha-Tec Systems000043072022-08-11
00816085020983Alpha-Tec Systems000043082022-08-11
00816085020990Alpha-Tec Systems000043092022-08-11
00816085023069Alpha-Tec Systems000034532022-08-11
00816085023670Alpha-Tec Systems000033712022-08-11
00816085024073Alpha-Tec Systems000048132022-08-11
00816085020075Alpha-Tec Systems0S0032222022-08-11
00816085020105Alpha-Tec Systems0S0032232022-08-11
00816085020273Alpha-Tec Systems02022-08-11
00816085020334Alpha-Tec Systems0S0032242022-08-11
00816085020167Alpha-Tec Systems00003248S2022-08-11
00816085020655Alpha-Tec Systems000033592022-08-11
00816085020877Alpha-Tec Systems0X0000202022-08-11
00816085020884Alpha-Tec Systems0X0034412022-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858092006192QBC DiagnosticsDRUCKER DIAGNOSTICSJSY2016-09-24
00858092006208QBC DiagnosticsDRUCKER DIAGNOSTICSJSY2016-09-24
00858092006215QBC DiagnosticsDRUCKER DIAGNOSTICSJSY2016-09-24
00858092006222QBC DiagnosticsDRUCKER DIAGNOSTICSJSY2016-09-24