FDA.report

Alpha-Tec Systems

Primary DI
00816085022871
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003436
Device description
Sodium Hydroxide Solution (4%)
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816085022864PrimaryGS10
00816085022871Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085022864008160850228648160850228640816085022864
00816085022871008160850228718160850228710816085022871

GMDN Terms

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

Regulatory Flags

DUNS number
103105524
Device count
5
DM exempt
false
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 DIBrandModelCatalogPublished
00816085020075Alpha-Tec Systems0S0032222022-08-11
00816085020105Alpha-Tec Systems0S0032232022-08-11
00816085020273Alpha-Tec Systems02022-08-11
00816085020334Alpha-Tec Systems0S0032242022-08-11
00816085020167Alpha-Tec Systems000032482022-08-11
00816085020655Alpha-Tec Systems000033592022-08-11
00816085020877Alpha-Tec Systems0X0000202022-08-11
00816085020884Alpha-Tec Systems0X0034412022-08-11
00816085020891Alpha-Tec Systems0X0034572022-08-11
00816085020914Alpha-Tec Systems000043022022-08-11
00816085021010Alpha-Tec Systems02022-08-11
00816085021027Alpha-Tec Systems02022-08-11
00816085021034Alpha-Tec Systems02022-08-11
00816085021041Alpha-Tec Systems02022-08-11
00816085021058Alpha-Tec Systems02022-08-11
00816085021065Alpha-Tec Systems02022-08-11
00816085021157Alpha-Tec Systems000042082022-08-11
00816085021171Alpha-Tec Systems000042102022-08-11
00816085021188Alpha-Tec Systems000042132022-08-11
00816085021195Alpha-Tec Systems000042162022-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENTDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFERDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891328849CHORUS SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
00847627043726NeoPath Background Punisher BIOCARE MEDICAL LLCPPM2026-03-11
04049016151302FITC-labelled anti-human IgA with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
00630414312460Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414312507Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
05407010129847Buffer C_SUO-001_Module L : 1000L BagLonza VerviersPPM2026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampLonza VerviersPPM2026-02-05
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)BIOCARE MEDICAL LLCPPM2026-01-29
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
05430003908471SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908693SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908631SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908709SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908730LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908785LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908808LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908846LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908860LaCAR Lacar MDX TechnologiesPPM2026-01-15
08435804522199FISH PT KITVITRO SAPPM2026-01-15
08435804522212DEWAX-2 FISHVITRO SAPPM2026-01-15
08435804522366FISH PT KITVITRO SAPPM2026-01-15
08435804522397DEWAX-2 FISH VITRO SAPPM2026-01-15