FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085020938
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0004303
Device description
NAC-PAC RED (3.0%) 5x50ml
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881698000ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.1988-05-13LDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085020938PrimaryGS10
00816085020266Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085020938008160850209388160850209380816085020938
00816085020266008160850202668160850202660816085020266

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.

Regulatory Flags#

DUNS number
103105524
Device count
5
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
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
00816085020891Alpha-Tec Systems0X0034572022-08-11

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