Alpha-Tec Systems

GUDID 00816085021027

NAC-PAC RED (2.5%) 50ml bottle

Alpha-TEC Systems, Inc.

Sputum specimen liquefaction/decontamination kit IVD
Primary Device ID00816085021027
NIH Device Record Key006299ed-f60b-4582-a76b-188ff0b716c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlpha-Tec Systems
Version Model Number0
Company DUNS103105524
Company NameAlpha-TEC Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816085020952 [Primary]
GS100816085021027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSKSupplement, Culture Media

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-19
Device Publish Date2022-08-11

On-Brand Devices [Alpha-Tec Systems]

00816085024103QC1 Malaria Slide
00816085020228Parasitology Stain QC Slides (+/-)
00816085020174Zn PVA QC Slides
00816085020150AFB Stain Control Slides
00816085020143AFB Stain Control Slides
00816085020136AFB Stain Control Slides
00816085020129Gram Stain Control Slide
00816085020112Gram Stain Control Slides With 3 Patient Wells
00816085020099Gram Stain QC Slides with one specimen well
00816085020082Gram Stain QC Slide
00816085023731QC1 Gram Negative Slide
00816085023748QC1 Gram Positive Slides
00816085023724QC1 AFB Negative Slides
00816085023717QC1 AFB Positive Slide
00816085023557Potassium Permanganate Counterstain 8x250ml bottle
00816085023038NALC Bulk 50g
00816085022987NALC Bulk 100g
00816085021591NAC-PAC RED (3.0%) 1x200ml
00816085020792Potassium Permanganate Stain 1x250ml
00816085020785TB Fluorescent Decolorizer 1x250ml
00816085023878CELL-BOND Slide, 1 Red well, no background
00816085023885CELL-BOND Slides, 3 black wells
00816085023892CELL-BOND Slides, no wells or background
00816085020198Cryptosporidium QC Slide
00816085023908CELL-BOND Slides, 2 wells [15mm], red background
00816085023915CELL-BOND Slides, 2 Wells, black background
00816085023922CELL-BOND Slides, 1 Well, black background
00816085023939CELL-BOND Slides, 1 Well, blue background
00816085023946CELL-BOND Slides, 2 Red Wells
00816085023953CELL-BOND Slides, 1 Well, black background
00816085023960CELL-BOND Slides, 1 Well, white background
00816085023977CELL-BOND Slides, 1 well, black background
00816085023984CELL-BOND Slides, 1 well, black background
00816085020280Trichomonas Quality Control Slide
00816085023588Ziehl-Neelsen Carbolfushsin Stain 8x250ml
00816085023564Auramine O/Rhodamine B Stain 8x250ml
00816085023526TB Fluorescent Decolorizer 8x250ml
00816085023502Auramine O Fluorescent Stain 8x250ml
00816085023489Methylene Blue Counterstain 8x250ml
00816085023465TB Decolorizer 8x250ml
00816085023441Kinyoun Carbolfuchsin Stain 8x250ml
00816085021997Thiazine Red Counterstain 8x250ml
00816085020853Ziehl-Neelsen Carbolfuchsin Stain 250ml bottle
00816085020846Methylene Blue Counterstain 250ml bottle
00816085020839TB Decolorizer 250ml bottle
00816085020822Kinyoun Carbolfuchsin Stain 250ml bottle
00816085020815Thiazine Red Counterstain 250ml bottle
00816085020808Auramine O Rhodamine B Stain 250ml bottle
00816085020778Auramine O Stain 250ml bottle
00816085024127VTM Viral Transport Medium Pack
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