FDA.report

MNG Single Blood Genetic Test

Primary DI
00850070779074
Company
Medzah Industries
Model
125221
Device description
MNG Single Blood Genetic Test
Published
2024-12-03
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

Regulatory Flags

DUNS number
114193536
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00850070779074PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00850070779074PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10860010472146Instant Cold Pack 6inx9inSAM-10012025-08-11
20860012637410Instant Cold Pack 4.75x7SAM-30002025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
20860011343879BIONEXBNMD012025-07-30
20860011343886BIONEXBNMD022025-07-30
20860011343893BIONEXBNMD032025-07-30
20860011725408BIONEXBNMD042025-07-30
20860011725415BIONEXBNMD052025-07-30
20860011917483MEDZAH INSTANT HOT PACKSAM-20002025-07-30
20860011917490MEDZAH INFANT HEEL WARMERSAM-1082025-07-30
20860012637403MEDZAH INSTANT HOT PACKSAM-20012025-07-30
00860009922730Medzah Steel Walkers with 5" WheelsMDZH904SE2025-03-07
00860009784895Ditek Urine Collection CupCP102212025-03-06
00860012637430SnapnSealEVON1022025-03-06
00850070779050MNG 5-Tube CSF Collection1252182024-12-03
00850070779067MNG TRIO Blood Testing1252202024-12-03
00850070779081MNG Buccal Swab1252222024-12-03
00850070779098MNG Blood Enzymology Testing1252232024-12-03
00850070779104MNG - PTC Collection Kit1337192024-12-03
00850070779111MNG - RNA Sequencing Collection Kit1389572024-12-03

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