FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085023786
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
X000401
Device description
Triton X-100 20%
Published
2022-08-11
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
JSKSupplement, Culture Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSKSupplement, Culture MediaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023786008160850237868160850237860816085023786

GMDN Terms#

Term, Definition table
TermDefinition
Faecal parasite specimen concentration kit IVDA collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103105524
Device count
1
Premarket exempt
true
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
05407010128727ProLipid Complex - 50 ml SAMPLELonza VerviersJSK2025-09-15
05407010128734ProLipid Complex - 1010 mlLonza VerviersJSK2025-09-15
05407010128741Rec. Hum. Insulin ( # 4506) Suppl - 10LLonza VerviersJSK2025-09-15
05407010128758Rec. Hum. Insulin ( # 4506) Suppl - 500LLonza VerviersJSK2025-09-15
05407010128765Mod ProCHO 5 powder Sup 2 - 20 mlLonza VerviersJSK2025-09-15
05407010128772Mod ProCHO 5 powder Sup 2 - 500LLonza VerviersJSK2025-09-15
05407010128284Ferric Citrate solution - 400 mlLonza VerviersJSK2025-08-11
05407010128246Insulin Solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128253Insulin Solution - 900 mlLonza VerviersJSK2025-08-08
05407010128260Ferric Citrate solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128277Ferric Citrate solution - 1L bottleLonza VerviersJSK2025-08-08
05407010127126DMEM Vitamines Stock 100x 1LLonza VerviersJSK2025-05-26
05407010127010MCDB 202 Trace Element BulkLonza VerviersJSK2025-05-23
05407010127034CHO4A Trace element stock - 1L bottleLonza VerviersJSK2025-05-23
05407010127041Stock solution CH-0107N (0.7g/L)Lonza VerviersJSK2025-05-23
05407010127058Stock solution SP-0180T (0.095 g/l)Lonza VerviersJSK2025-05-23
05407010127065Stock solution CH-0146T (0.078 g/l)Lonza VerviersJSK2025-05-23
05407010127072Stock solution CH-0242 (0.4711 g/l)Lonza VerviersJSK2025-05-23
05407010127089Stock solution CH-0116N (0.2162 g/l)Lonza VerviersJSK2025-05-23
05407010127096Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127102Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127119CHO7 Lipids 2x 500 ml (resa CSL Behring)Lonza VerviersJSK2025-05-23
05407010126976Lipid Mix CM-105 NN It.no.101-5986-500mlLonza VerviersJSK2025-05-20
05407010126983Lipid Mix CM-105 NN It.no.101-5986 - 20LLonza VerviersJSK2025-05-20
05407010126648SF5-16 Powder Medium - Sup 1 for 5LLonza VerviersJSK2025-04-17
05407010126655SF5-16 Powder Medium - Sup 1 for 500LLonza VerviersJSK2025-04-17
05407010126662SF5-16 Powder Medium - Sup 2 - 5LLonza VerviersJSK2025-04-17
05407010126679SF5-16 Powder Medium - Sup 2 - 500LLonza VerviersJSK2025-04-17
05407010126426proVero complement powder - 500LLonza VerviersJSK2025-03-31
05407010126327GSK-IC-01 supplem. powder 200LLonza VerviersJSK2025-03-25