FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085023380
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003481
Device description
XPR-Plus Neutralizing Buffer 8x250ml
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

Product Codes#

Code, Name table
CodeName
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023311PrimaryGS10
00816085023380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023311008160850233118160850233110816085023311
00816085023380008160850233808160850233800816085023380

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
8
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 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
04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15
00810170553585IHCSlmp, LLCJCC2025-03-31
00810170553592IHCSlmp, LLCJCC2025-03-31
08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
00348783012699BufferProPREMIER DENTAL PRODUCTS COMPANYJCC2024-12-18
00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780557Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780564Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780595Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
07540207107803EasySep™ BufferStemcell Technologies Canada IncJCC2024-02-08
00380740136994AlinityAbbott Ireland DiagnosticsJCC2023-11-16
00860001977349OnsetOnpharma CompanyJCC2023-06-01
00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014559Immunocare PBS 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014610TBSplus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701468920% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
00847627014641TBS Auto Wash Buffer 20XBIOCARE MEDICAL LLCJCC2022-09-23
00847627014658TBS Auto Wash Buffer 40XBIOCARE MEDICAL LLCJCC2022-09-23
00816085023311Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085023328Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085020259Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10